Drug Quality Sampling and Testing Programs

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Background

FDA's requirements for approval of new and generic drugs and biologics are among the highest standards across the globe. Prior to FDA approval, manufacturers must prove that their products are high quality, safe, effective, and free of contamination and defects. In addition, manufacturers of non-application products, such as over-the-counter and homeopathic products, are responsible for adhering to quality standards. Pharmaceutical manufacturers, no matter where they are located, are responsible for complying with Current Good Manufacturing Practice and ensuring that only quality products reach U.S. patients.

Learn more about how CDER keeps patients and consumers safe: CDER’s Drug Quality Sampling and Testing program

To help ensure that high-quality drugs are sold in the U.S., CDER maintains a comprehensive quality surveillance program. A critical function of this program is testing selected drugs in FDA laboratories. This includes testing active pharmaceutical ingredients (APIs). FDA laboratories generally test drugs to standards set by the U.S. Pharmacopeia (USP), an organization that publishes quality monographs for medicines including attributes such as:

• Identity – is it the right drug as indicated on the label?
• Assay – how much drug is there and is it consistent with the labeled amount?
• Impurities – are impurities within established specifications?
• Dissolution – does the active ingredient dissolve out of the dosage unit so that the drug is available for the body to absorb?

CDER’s quality surveillance program includes multiple tools that complement sampling and testing, including inspections, evaluation of post-market quality reports, signal detection, and data analysis.

We at CDER are committed to protecting patients and consumers from unsafe, ineffective or poor-quality drugs.

Testing

The FDA uses a risk-based approach to quality testing. This means that in cases where there is a known or likely safety, effectiveness, or quality issue with a product, FDA scientists perform specific tests for this vulnerability. As you can see in the results below, the majority of drugs FDA tests meet their specifications.

Beginning in 2018, CDER began using data analytics, including post-market quality data, to identify products that have potential quality risks. This more targeted, risk-based approach for sampling and testing has been effective in helping us identify more products per year that fail quality tests than in the years prior to 2018.

If drug products have unfavorable testing results, CDER works swiftly to protect the public from potential harm. CDER shares information with health care professionals and consumers to help them make decisions. In addition, CDER alerts the manufacturer of the need to take measures to correct the problem underlying the unfavorable test results. CDER continues to monitor the situation until the manufacturer demonstrates compliance with FDA rules and regulations.

These surveillance testing results are from CDER’s Drug Quality Sampling and Testing Program.

Results

FY 24 Results

Drug Name	Trade Name	Dosage Form	Firm	Tests Performed	Why Tested	Results
Acetaminophen	NA	GELCAP	Elysium Pharmaceuticals Limited	Identification, Assay, Dissolution, Impurities	Annual surveillance sampling and testing	Passed Tests
Atorvastatin Calcium	NA	TABLET	Aphena Pharma Solutions	Identification, Assay, Dissolution, Impurities	Annual surveillance sampling and testing	Passed Tests
Atropine Sulfate	NA	SOLUTION	Amneal Pharmaceuticals Private Limited	Sterility	Import surveillance sampling and testing	Passed Test
Bupivacaine Hydrocholoride	NA	INJECTION	Hospira, Inc.	Identification, Assay, Impurities, Assay for Dextrose, pH, Visual Examination, Sterility, Bacterial Endotoxins	Annual surveillance sampling and testing	Passed Tests
Bupropion Hydrochloride	NA	TABLET	A-S Medication Solutions LLC	Identification, Assay, Dissolution, Impurities	Annual surveillance sampling and testing	Passed Tests
Bupropion Hydrochloride	NA	TABLET	AvKARE/AvPAK	Identification, Assay, Dissolution, Impurities	Annual surveillance sampling and testing	Passed Tests
Bupropion Hydrochloride	NA	TABLET, EXTENDED RELEASE	Intas Pharmaceuticals Limited	Identification, Assay, Dissolution, Impurities	Import surveillance sampling and testing	Passed Tests
Bupropion Hydrochloride	NA	TABLET, EXTENDED RELEASE	Lupin Limited	Identification, Assay, Impurities	Import surveillance sampling and testing	Passed Tests
Calcium Chloride, Dextrose, Magnesium Chloride, Sodium Chloride, Sodium Lactate, Peritoneal Dialysis	Deflex	SOLUTION	Fresenius Medical Care North America	Assay, pH, Visual Examination, Sterility, Bacterial Endotoxins	Annual surveillance sampling and testing	Passed Tests
Carbamazepine	NA	TABLET, CHEWABLE	Taro Pharmaceutical Industries LTD	Identification, Assay, Dissolution, Impurities	Annual surveillance sampling and testing	Passed Tests
Childrens Tylenol	NA	SUSPENSION	Johnson & Johnson Consumer Inc	Identification, Assay, pH	Annual surveillance sampling and testing	Passed Tests
Chlorhexidine Gluconate	NA	SOLUTION	Bajaj Medical LLC	Identification, Assay, pH, Limit of p-Chloroaniline, Visual Examination	Annual surveillance sampling and testing	Passed Tests
Chlorhexidine Gluconate	NA	SOLUTION	Xttrium Laboratories Inc	Identification, Assay, pH, Limit of p-Chloroaniline, Visual Examination	Annual surveillance sampling and testing	Passed Tests
Calcium Chloride	Dianeal	INJECTION, SOLUTION	Baxter Healthcare Corporation	Identification, Assay, pH, Particulate Matter	Annual surveillance sampling and testing	Passed Tests
Divalproex Sodium	NA	TABLET, EXTENDED RELEASE	Lupin Limited	Identification, Assay, Dissolution, Impurities	Annual surveillance sampling and testing	Passed Tests
Donepezil Hydrochloride	NA	TABLET	Macleods Pharmaceuticals Limited	Identification, Assay, Impurities	Import surveillance sampling and testing	Passed Tests
Doxycycline Hyclate	NA	TABLET	Amerisource Health Services LLC	Identification, Assay, Dissolution, Impurities	Annual surveillance sampling and testing	Passed Tests
Enalapril Maleate	NA	TABLET	Zhejiang Huahai Pharmaceutical Co., Ltd	Identification, Assay, Impurities	Import surveillance sampling and testing	Passed Tests
Famotidine	NA	TABLET	Annora Pharma Private Limited	Identification, Assay, Impurities	Import surveillance sampling and testing	Passed Tests
Famotidine	NA	TABLET	Dr Reddy'S Laboratories Limited	Identification, Assay, Impurities	Import surveillance sampling and testing	Passed Tests
Felodipine	NA	TABLET, EXTENDED RELEASE	Torrent Pharmaceuticals Limited	Identification, Assay, Impurities	Import surveillance sampling and testing	Passed Tests
Glipizide	NA	TABLET	Apotex Inc	Identification, Assay, Impurities	Annual surveillance sampling and testing	Passed Tests
Glipizide	NA	TABLET	Zydus Lifesciences Limited	Identification, Assay, Impurities	Import surveillance sampling and testing	Passed Tests
Good Neighbor	NA	SUSPENSION	L. Perrigo Company	Identification, Assay, 4-Aminophenol relative to Acetominophen, pH	Annual surveillance sampling and testing	Passed Tests
Hydralazine Hydrochloride	NA	TABLET	Annora Pharma Pvt LTD	Identification, Assay, Dissolution, Impurities	Annual surveillance sampling and testing	Passed Tests
Hydralazine Hydrochloride	NA	TABLET	Strides Pharma Science Limited	Identification, Assay, Impurities	Import surveillance sampling and testing	Passed Tests
Isotretinoin	NA	CAPSULE	Dr. Reddy's Laboratories Limited	Identification, Assay, Impurities	Import surveillance sampling and testing	Passed Tests
Lactated Ringer's	NA	INJECTION, SOLUTION	B. Braun Medical Inc	Identification, Assay, Container Closure Integrity, pH, Sterility, Bacterial Endotoxins, Particulate Matter	Annual surveillance sampling and testing	Passed Tests
Lansoprazole	NA	CAPSULE, MODIFIED RELEASE	Inventia Healthcare Limited	Identification, Assay, Dissolution, Impurities, Visual Examination	Import surveillance sampling and testing	Passed Tests
Lansoprazole	NA	CAPSULE, MODIFIED RELEASE	Mylan Laboratories Limited	Identification, Assay, Dissolution, Impurities, Visual Examination	Import surveillance sampling and testing	Passed Tests
Alcaftadine	Lastacaft	SOLUTION	Allergan Sales, LLC	Identification, Assay, Impurities, Benzalkonium Chloride, Visual Examination, pH, Sterility, Particulate Matter	Annual surveillance sampling and testing	Passed Tests
Levetiracetam	NA	TABLET	Zhejiang Huahai Pharmaceutical	Identification, Assay, Impurities	Import surveillance sampling and testing	Passed Tests
Levothyroxine Sodium	NA	TABLET	Lupin Limited	Identification, Assay, Impurities	Import surveillance sampling and testing	Passed Tests
Levothyroxine Sodium	NA	TABLET	Allergan Sales, LLC	Identification, Assay	Annual surveillance sampling and testing	Passed Tests
Levothyroxine; Liothyronine	NA	TABLET	Allay Pharmaceuticals, LLC	Identification, Assay	Annual surveillance sampling and testing	Passed Tests
Memantine Hydrochloride	NA	TABLET	Dr. Reddy's Laboratories Limited	Identification, Assay, Dissolution, Impurities	Annual surveillance sampling and testing	Passed Tests
Mirtazapine	NA	TABLET	American Health Packaging, Inc	Identification, Assay, Dissolution, Impurities	Annual surveillance sampling and testing	Passed Tests
Naproxen Sodium	NA	TABLET	Amneal Pharmaceuticals	Identification, Assay, Dissolution, Impurties	Annual surveillance sampling and testing	Passed Tests
Nicardipine Hydrochloride	NA	INJECTION	Excela Pharma Sciences, LLC	Identification, Assay, Impurities, pH, Particulate Matter, Sterility, Bacterial Endotoxins	Annual surveillance sampling and testing	Passed Tests
Nicardipine Hydrochloride	NA	INJECTION	Hikma Farmaceutica (Portugal), S.A	Identification, Assay, Impurities, pH, Particulate Matter, Sterility, Bacterial Endotoxins	Annual surveillance sampling and testing	Passed Tests
Nifedipine	NA	TABLET, EXTENDED RELEASE	Lannett Company Inc.	Identification, Assay, Impurities	Annual surveillance sampling and testing	Passed Tests
Paliperidone	NA	TABLET, EXTENDED RELEASE	Inventia Healthcare Limited	Identification, Assay, Dissolution, Impurities	Import surveillance sampling and testing	Passed Tests
Paroxetine Hydrochloride	NA	TABLET	Aphena Pharma Solutions	Identification, Assay, Dissolution, Impurities	Annual surveillance sampling and testing	Passed Tests
Pataday	NA	SOLUTION	Alcon Research LLC	Identification, Assay, Limit of Early Eluting Impurities, Limit of Late Eluting Impurities, pH, Visual Examination, Sterility	Annual surveillance sampling and testing	Passed Tests
Pravastatin Sodium	NA	TABLET	Mylan Pharmaceuticals Inc	Identification, Assay, Dissolution, Impurities	Annual surveillance sampling and testing	Passed Tests
Propofol	NA	INJECTION, EMULSION	Emcure Pharmaceuticals Limited	Identification, Assay, Impurities	Import surveillance sampling and testing	Passed Tests
Relieva PF Lubricant Eye Drops	NA	SOLUTION	Allergan Sales, LLC	Assay, pH, Sterility	Annual surveillance sampling and testing	Passed Tests
Risperidone	NA	TABLET	Ajanta Pharma Limited	Identification, Assay, Dissolution, Impurities	Annual surveillance sampling and testing	Passed Tests
Sertraline Hydrochloride	NA	TABLET	Lupin Limited	Identification, Assay, Impurities	Import surveillance sampling and testing	Passed Tests
Simvastatin	NA	TABLET	Aurobindo Pharma Limited	Identification, Assay, Impurities	Import surveillance sampling and testing	Passed Tests
Sirolimus	NA	TABLET	Dr. Reddy's Laboratories Limited	Identification, Assay, Dissolution, Impurities	Annual surveillance sampling and testing	Passed Tests
Sodium Chloride	NA	INJECTION, SOLUTION	Laboratorios Grifols, S.A	Identification, Assay, Impurities, Sterility	Import surveillance sampling and testing	Passed Tests
Sodium Nitroprusside	NA	INJECTION, SOLUTION	Hainan Poly Pharm. Co., Ltd	Identification, Assay	Import surveillance sampling and testing	Passed Tests
Sterile Water For Injection	NA	INJECTION	B. Braun Medical Inc	pH, Water Conductivity, Sterility, Bacterial Endotoxins, Particulate Matter, Container Closure Integrity	Annual surveillance sampling and testing	Passed Tests
Sumatriptan Succinate	NA	TABLET	Aurobindo Pharma Limited	Identification, Assay, Impurities, Visual Examination, Microbial Enumeration	Import surveillance sampling and testing	Passed Tests

FY 23 Results

Drug Name	Trade Name	Dosage Form	Firm	Tests Performed	Why Tested	Results
Fentanyl and 0.1% Ropivacaine HCl in 0.9% Sodium Chloride	NA	INJECTION FOR EPIDURAL USE	QuVa Pharma, Inc	Identification, Assay, Economically Motivated Adulteration	Opioid surveillance	Passed Tests
Fentanyl and 0.1% Bupivacaine HCl in 0.9% Sodium Chloride	NA	INJECTION FOR EPIDURAL USE	QuVa Pharma, Inc	Identification, Assay, Economically Motivated Adulteration	Opioid surveillance	Passed Tests
Fentanyl and 0.2% Ropivacaine HCl in 0.9% Sodium Chloride	NA	INJECTION FOR EPIDURAL USE	QuVa Pharma, Inc	Identification, Assay, Economically Motivated Adulteration	Opioid surveillance	Passed Tests
Fentanyl in 0.9% Sodium Chloride	NA	INJECTION FOR IV USE	SCA Pharmaceuticals, Inc.	Identification, Assay, Economically Motivated Adulteration	Opioid surveillance	Passed Tests
Fentanyl	NA	INECTION, IV BAG	SCA Pharmaceuticals, Inc.	Identification, Assay, Economically Motivated Adulteration	Opioid surveillance	Passed Tests
Fentanyl and 0.125% Bupivacaine HCl in 0.9% Sodium Chloride	NA	INJECTION FOR EPIDURAL USE	SCA Pharmaceuticals, Inc.	Identification, Assay, Economically Motivated Adulteration	Opioid surveillance	Passed Tests
Buprenorphrine Hydrochloride and Naloxone	NA	TABLETS	Sun Pharmaceutical Industries Limited	Identification, Assay, Economically Motivated Adulteration	Opioid surveillance	Passed Tests
Tramadol Hydrochloride	NA	TABLETS	Teva Czech Industries s.r.o.	Identification, Assay, Economically Motivated Adulteration	Opioid surveillance	Passed Tests
Tramadol Hydrochloride	NA	TABLETS	Unichem Laboratories Ltd.	Identification, Assay, Economically Motivated Adulteration	Opioid surveillance	Passed Tests
Buprenorphine HCl	NA	SUBLINGUAL TABLETS	Sun Pharmaceutical Industries Limited	Identification, Assay, Economically Motivated Adulteration	Opioid surveillance	Passed Tests
Buprenorphine HCl and Naloxone HCl Dihydrate	NA	TABLETS	Sun Pharmaceutical Industries Limited	Identification, Assay, Economically Motivated Adulteration	Opioid surveillance	Passed Tests
Fentanyl Citrate	NA	INJECTION, IV BAG	Medi-Fare Drug	Identification, Assay, Economically Motivated Adulteration	Opioid surveillance	Passed Tests
Tramadol Hydrochloride and Acetaminophen	NA	TABLETS	Amneal Pharmaceuticals Pvt. Ltd.	Identification, Assay, Economically Motivated Adulteration	Opioid surveillance	Passed Tests
Fentanyl Citrate and Bupivicaine	NA	INJECTION, IV BAG	Medi-Fare Drug	Identification, Assay, Economically Motivated Adulteration	Opioid surveillance	Passed Tests
Tramadol Hydrochloride	NA	TABLETS	Lupin Limited	Identification, Assay, Economically Motivated Adulteration	Opioid surveillance	Passed Tests
Tramadol Hydrochloride	NA	TABLETS	Sun Pharmaceutical Industries Limited	Identification, Assay, Economically Motivated Adulteration	Opioid surveillance	Passed Tests
Morphine Sulfate	NA	INJECTION, FOR IV USE	QuVa Pharma, Inc	Identification, Assay, Economically Motivated Adulteration	Opioid surveillance	Passed Tests
Morphine Sulfate	NA	INJECTION	SSM Health Care St. Louis DBA SSM St. Clare Health Center	Identification, Assay, Economically Motivated Adulteration	Opioid surveillance	Passed Tests
Hydromorphone HCl 10 mg in 0.9% sodim chloride (0.2mg/mL)	NA	INJECTION, FOR IV USE	QuVa Pharma, Inc	Identification, Assay, Economically Motivated Adulteration	Opioid surveillance	Passed Tests
Hydromorphone HCl 30 mg/30 mL in 0.9% sodium chloride (1mg/mL)	NA	INJECTION, FOR IV USE	QuVa Pharma, Inc	Identification, Assay, Economically Motivated Adulteration	Opioid surveillance	Passed Tests
Methadone HCl 1mg/1mL in 0.9% sodium chloride	NA	INJECTION, FOR EPIDURAL USE	QuVa Pharma, Inc	Identification, Assay, Economically Motivated Adulteration	Opioid surveillance	Passed Tests
Morphine Sulfate 50 mg in 0.9% sodium chloride (1mg/1mL)	NA	INECTION, FOR IV USE	QuVa Pharma, Inc	Identification, Assay, Economically Motivated Adulteration	Opioid surveillance	Passed Tests
Fentanyl	NA	INJECTION, FOR IV USE	QuVa Pharma, Inc	Identification, Assay, Economically Motivated Adulteration	Opioid surveillance	Passed Tests
Donepezil Hydrochloride	NA	TABLETS	Macleods Pharmaceuticals Ltd	Assay, Organic Impurities, Dissolution, Identity, Content Uniformity	Quality surveillance after inspection was classified as OAI (Official Action Indicated)	Passed Tests
Olanzapine	NA	ORALLY DISINTEGRATING TABLETS	Macleods Pharmaceuticals Ltd	Identity, Assay, Content Uniformity, Organic Impurities, Dissolution	Quality surveillance after inspection was classified as OAI (Official Action Indicated)	Passed Tests
Olanzapine	NA	TABLETS	Macleods Pharmaceuticals Ltd	Identity, Assay, Content Uniformity, Organic Impurities, Dissolution	Quality surveillance after inspection was classified as OAI (Official Action Indicated)	Passed Tests
Zanosar	NA	POWDER FOR SOLUTION FOR INFUSION	Keocyt: France	Assay, Impurities	Quality assessment of an unapproved drug product to mitigate a drug shortage of a medically necessary product	Passed Tests
Brimonidine Tartrate	Lumify	OPHTHALMIC	Bausch & Lomb	Benzalkonium Chloride Content, Brimonidine Tartate Content, Related Substances, pH	Quality surveillance of copycat products	Passed Tests
Elexacaftor and Tezacaftor and Ivacaftor	NA	TABLET	Vertex Pharmaceuticals Incorporated	Assay, Dissolution, Content Uniformity, Impurities	Annual surveillance sampling and testing	Passed Tests
Verzenio (Abemaciclib)	NA	TABLET	Lilly Del Caribe, Inc.	Assay, Dissolution, Content Uniformity, Impurities	Annual surveillance sampling and testing	Passed Tests
Cyclobenzaprine Hydrochloride	NA	TABLET	Jubilant Cadista Pharmaceuticals Inc	Identification,Dissolution, Uniformity Of Dosage Units, Organic Impurities	Annual surveillance sampling and testing	Passed Tests
Atorvastatin Calcium	NA	TABLET, FILM COATED	Ohm Laboratories Inc.	Identification, Assay, Dissolution, Visual Examination of Tablets and Foreign Material in Container	Annual surveillance sampling and testing	Passed Tests
Pantoprazole Sodium	NA	TABLET	Lannett Company, Inc.	Visual Examination of Tablets and Foreign Material in Container, Identification, Dissolution, Uniformity Of Dosage Units, Organic Impurities	Annual surveillance sampling and testing	Passed Tests
Levetiracetam Tablet	NA	TABLET	Zhejiang Huahai Pharmaceutical	Identification; Content Uniformity; Dissolution; Organic Impurities	Import surveillance sampling and testing	Organic Impurity - Failed Test; Identification, Content Uniformity, and Dissolution - Passed Tests
Heparin Sodium	NA	INJECTION	Nanjing Kingfriend Biochemical Pharmaceutical Corporation Ltd	OSCS Impurity; Benzyl Alcohol Content; Sterility; Bacterial Endotoxins; Particulate Matter In Injections; pH	Import surveillance sampling and testing	Passed Tests
Heparin Sodium	NA	INJECTION	Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd.	OSCS Impurity	Heparin assignment	Passed Tests
Crude Heparin	NA	CRUDE HEPARIN	Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd.	OSCS Impurity	Heparin assignment	Passed Tests
Levetiracetam	NA	TABLET	Zhejiang Huahai Pharmaceutical Co., Ltd.	Dissolution	Annual surveillance sampling and testing	Passed Tests
Heparin Sodium	NA	INJECTION	Aurobindo Pharma Limited - Unit Iv	OSCS Impurity	Heparin assignment	Passed Tests
Bupivacaine Hydrochloride	NA	INJECTION	Hospira, Inc.	Identification, Assay, Impurities, Assay For Dextrose, pH, Visual Examination, Sterility, Bacterial Endotoxins	Quality Surveillance Sampling and Testing	Passed Tests
Nitrofurantoin	NA	SUSPENSION	Nostrum Laboratories Inc.	Identification, Uniformity Of Dosage Units, Dissolution	Annual surveillance sampling and testing	Passed Tests
Potassium Acetate	NA	INJECTION	Excela Pharma Sciences, Llc	Aluminum	Initiative Surveilance Sampling and Testing	Passed Tests
Clonidine HCl	NA	TABLET	Xiamen Lp Pharmaceutical Co., Ltd.	Identification; Content Uniformity; Dissolution; Organic Impurities	Import surveillance sampling and testing	Passed Tests
Levetiracetam Tablet	NA	TABLET	Zhejiang Huahai Pharmaceutical	Identification; Content Uniformity; Dissolution; Organic Impurities	Import surveillance sampling and testing	Passed Tests
Phenylephrine Hydrochloride	NA	INJECTION	Nanjing Kingfriend Biochemical Pharmaceutical Corporation Ltd	Identification; Assay; Organic Impurities; Sterility; Bacterial Endotoxins; Particulate Matter In Injections; pH	Import surveillance sampling and testing	Passed Tests
Isotretinoin	NA	CAPSULE	Galephar Pharmaceutical Research Inc.	Identification,Dissolution, Uniformity Of Dosage Units, Organic Impurities	Annual surveillance sampling and testing	Passed Tests
Vigabatrin Powder	NA	POWDER FOR ORAL SOLUTION	Par Formulations Private Limited	Identification; Assay; Impurities; Content Uniformity	Import surveillance sampling and testing	Passed Tests
Lithium Carbonate	NA	EXTENDED RELEASE TABLETS	Mylan Laboratories Limited	Friability; Tablet Hardness	Import surveillance sampling and testing	Passed Tests
Invokana	NA	TABLET	Janssen Ortho Llc	Assay, Dissolution, Content Uniformity	Annual surveillance sampling and testing	Passed Tests
Bupropion Hydrochloride	NA	TABLETS	Zhejiang Huahai Pharmaceutical	Identification; Content Uniformity; Dissolution; Organic Impurities	Import surveillance sampling and testing	Passed Tests
Metoprolol Tartrate	NA	TABLET	Rubicon Research Private Limited	Visual Examination of Tablets and Foreign Material in Container, Identification, Uniformity Of Dosage Units, Organic Impurities	Annual surveillance sampling and testing	Passed Tests
Crude Heparin	NA	MUCOUS SODIUM LINING OF PIG INTESTINES	Sanimax Lom Inc.	OSCS Impurity	Heparin assignment	Passed Tests
Atomoxetine Hydrochloride	NA	CAPSULE	Glenmark Pharmaceuticals Limited	Identification; Assay; Content Uniformity; Dissolution; Impurities	Import surveillance sampling and testing	Passed Tests
Heparin Sodium	NA	INJECTION	Gland Pharma Limited	OSCS Impurity	Heparin assignment	Passed Tests
Atorvastatin Calcium	NA	TABLET, FILM COATED	Ohm Laboratories Inc.	Identification, Assay, Dissolution, Visual Examination Of Tablets, Foreign Material In Container	Annual surveillance sampling and testing	Passed Tests
Invokana	NA	TABLET	Janssen Ortho Llc	Assay, Dissolution, Content Uniformity	Annual surveillance sampling and testing	Passed Tests
Isotretinoin	NA	CAPSULE	Galephar Pharmaceutical Research Inc.	Identification,Dissolution, Uniformity Of Dosage Units, Organic Impurities	Annual surveillance sampling and testing	Passed Tests
Metoprolol Tartrate	NA	TABLET	Rubicon Research Private Limited	Visual Examination Of Tablets and Foreign Material in Container, Identification, Uniformity Of Dosage Units, Organic Impurities	Annual surveillance sampling and testing	Passed Tests
Phenylephrine Hydrochloride	NA	INJECTION	Nanjing Kingfriend Biochemical Pharmaceutical Corporation Ltd	Identification; Assay; Organic Impurities; Sterility; Bacterial Endotoxins; Particulate Matter In Injections; pH	Import surveillance sampling and testing	Passed Tests
Piperacillin and Tazobactam	NA	POWDER	QILU TIANHE PHARMACEUTICAL CORPORATION LTD	Identification; Assay; Organic Impurities; Sterility; Bacterial Endotoxins; Particulate Matter In Injections; pH	Import surveillance sampling and testing	Passed Tests
Cisatracurium Besylate	NA	INJECTION	NANJING KINGFRIEND BIOCHEMICAL PHARMACEUTICAL CORPORATION LTD	Identification; Assay; Organic Impurities; Sterility ; Bacterial Endotoxins; Particulate Matter In Injections; pH	Import surveillance sampling and testing	Passed Tests
Calcipotriene	NA	EMULSION, CREAM	LEO LABORATORIES LIMITED	Identification, Assay, pH, Microbial Enumeration Tests, Specificed Microorganisms	Annual surveillance sampling and testing	Passed Tests
Chlorhexidine Gluconate	NA	SOLUTION	PHARMACEUTICAL ASSOCIATES INC	Identification, Assay, pH	Annual surveillance sampling and testing	Passed Tests
Chlorhexidine Gluconate	NA	LIQUID	COLGATEPALMOLIVE COMPANY	Identification, Assay, pH	Annual surveillance sampling and testing	Passed Tests
Chlorthalidone	NA	TABLET	AJANTA PHARMA LIMITED	Identification, Dissolution, Uniformity Of Dosage Units	Annual surveillance sampling and testing	Passed Tests
Cisatracurium Besylate	NA	INJECTION	NANJING KINGFRIEND BIOCHEMICAL PHARMACEUTICAL CORPORATION LTD	Identification; Assay; Organic Impurities; Sterility; Bacterial Endotoxins; Particulate Matter In Injection; pH	Import surveillance sampling and testing	Passed Tests
Doxylamine Succinate and Pyridoxine Hydrochloride	NA	TABLET, DELAYED RELEASE	Par Formulations Private Limited	Identification, Assay, Content Uniformity, Dissolution, Related Substances	Annual surveillance sampling and testing	Passed Tests
Duloxetine Hydrochloride	NA	CAPSULE, DELAYED RELEASE	AJANTA PHARMA LIMITED	Visual Examination of Capsules and Foreign Material in Container, Identification, Assay, Dissolution, Organic Impurities	Annual surveillance sampling and testing	Passed Tests
Duloxetine Hydrochloride	NA	CAPSULE, DELAYED RELEASE	AJANTA PHARMA LIMITED	Visual Examination of Capsules and Foreign Material in Container, Identification, Assay, Dissolution, Organic Impurities	Annual surveillance sampling and testing	Passed Tests
Elexacaftor and Tezacaftor and Ivacaftor	NA	TABLET	Vertex Pharmaceuticals Incorporated	Assay, Dissolution, Content Uniformity, Impurities	Annual surveillance sampling and testing	Passed Tests
Heparin Sodium	NA	INJECTION	Bioiberica, SAU	OSCS Impurity	Heparin assignment	Passed Test
Lamivudine	NA	TABLET	APOTEX INC	Identification, Dissolution, Uniformity Of Dosage Units, Organic Impurities, Friability	Annual surveillance sampling and testing	Passed Tests
Nicotine Polacrilex	NA	TROCHE	L PERRIGO COMPANY	Identification, Assay, Nicotine Release, Organic Impurities, Water Determination	Annual surveillance sampling and testing	Passed Tests
Orkambi	NA	TABLET	Vertex Pharmaceuticals Incorporated	Assay, Dissolution, Content Uniformity	Annual surveillance sampling and testing	Passed Tests
Paliperidone	NA	TABLET	CSPC OUYI PHARMACEUTICAL CO., LTD.	Identification, Assay, Content Uniformity, Dissolution, Related Substances	Annual surveillance sampling and testing	Passed Tests
Phenylephrine Hydrochloride	NA	INJECTION	NANJING KINGFRIEND BIOCHEMICAL PHARMACEUTICAL CORPORATION LTD	Identification; Assay; Organic Impurities; Sterility; Bacterial Endotoxins; Particulate Matter In Injections; pH	Import surveillance sampling and testing	Passed Tests
Piperacillin and Tazobactam	NA	POWDER	QILU TIANHE PHARMACEUTICAL CORPORATION LTD	Identification; Assay; Organic Impurities; Sterility; Bacterial Endotoxins; Particulate Matter In Injections; pH	Import surveillance sampling and testing	Passed Tests
Potassium Chloride	NA	TABLET, EXTENDED RELEASE	BORA PHARMACEUTICAL LABORATORIES INC.	Identificaton, Assay, Dissolution, Uniformity Of Dosage Units	Annual surveillance sampling and testing	Passed Tests
Valganciclovir	NA	TABLET	AJANTA PHARMA LIMITED	Identification, Assay, Dissolution, Uniformity Of Dosage Units, Organic Impurities	Annual surveillance sampling and testing	Passed Tests

FY 22 Results

Drug Name	Trade Name	Dosage Form	Firm	Tests Performed	Why Tested	Result
Hand Sanitizer	NA	LIQUID	Cardinal Spirits	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Assay; Failed Impurities
Hand Sanitizer	Seatex Hand Sanitizer Alcohol Antisepetic 80% Topical Solution	LIQUID	Seatex, LLC	Assay, Impurities	Hand Sanitizer sampling and testing	Failed Tests
Hand Sanitizer	Unlabeled	LIQUID	HS BEVERAGE INC.	Assay, Impurities	Hand Sanitizer sampling and testing	Assay does not meet label claim but within efficacy range; Failed Impurities
Hand Sanitizer	LUCAS HAND SANITIZER Alcohol Antiseptic 80% Topical Solution Non-Sterile Solution	LIQUID	Lucas Oil Racing, Inc.	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Assay; Failed Impurities
Hand Sanitizer	Big Machine Distillery HAND SANITIZER NON-STERILE SOLUTION ALCOHOL ANTISEPTIC 80% TOPICAL SOLUTION	LIQUID	Tenn South Distillery LLC dba Big Machine Distillery	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Assay; Failed Impurities
Hand Sanitizer	NA	LIQUID	Alltech, Inc.	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Assay; Failed Impurities
Hand Sanitizer	NA	LIQUID	Proof Brewing Company	Assay, Impurities	Hand Sanitizer sampling and testing	Assay does not meet label claim but within efficacy range; Failed Impurities
Hand Sanitizer	NA	LIQUID	Donati Family Vineyard, inc	Assay, Impurities	Hand Sanitizer sampling and testing	Assay does not meet label claim but within efficacy range; Failed Impurities
Hand Sanitizer	NA	LIQUID	Donati Family Vineyard, inc	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Assay; Failed Impurities
Hand Sanitizer	NA	LIQUID	Mayor Pharmaceutical Laboratories inc	Assay, Impurities, Microbial Enumeration Test and Tests for Specified Micro-Organisms	Hand Sanitizer sampling and testing	Assay does not meet label claim but within efficacy range; Passed Impurities; Passed Microbial Enumeration Test and Tests for Specified Micro-Organisms
Hand Sanitizer	NA	LIQUID	Sapthre Maple Syrup	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Assay; Failed Impurities
Hand Sanitizer	NA	LIQUID	Kronebusch Industries	Assay, Impurities	Hand Sanitizer sampling and testing	Assay does not meet label claim but within efficacy range; Failed Impurities
Hand Sanitizer	NA	GEL	Vincit Ze Company	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Tests
Hand Sanitizer	NA	GEL	Vincit Ze Company	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Tests
Hand Sanitizer	NA	GEL	Vincit Ze Company	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Tests
Hand Sanitizer	NA	LIQUID	Sutherland Distilling Company, LLC	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Assay; Failed Impurities
Hand Sanitizer	NA	LIQUID	Frank-Lin Distillers Products, Ltd.	Assay, Impurities, Microbial Enumeration Test and Tests for Specified Micro-Organisms	Hand Sanitizer sampling and testing	Passed Assay, Failed Impurities; Passed Microbial Enumeration Test and Tests for Specified Micro-Organisms
Hand Sanitizer	NA	LIQUID	Indigeny Reserve	Assay, Impurities, Microbial Enumeration Test and Tests for Specified Micro-Organisms	Hand Sanitizer sampling and testing	Passed Assay, Failed Impurities; Passed Microbial Enumeration Test and Tests for Specified Micro-Organisms
Hand Sanitizer	NA	LIQUID	CLASSIC WINE VINEGAR COMPANY INC	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Assay; Failed Impurities
Hand Sanitizer	NA	LIQUID	Lena Brewing Company	Assay, Impurities	Hand Sanitizer sampling and testing	Assay does not meet label claim but within efficacy range; Failed Impurities
Hand Sanitizer	NA	LIQUID	Lubriformance, LLC	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Tests
Hand Sanitizer	NA	LIQUID	Tribal Vapor Dallas	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Tests
Hand Sanitizer	NA	LIQUID	BENDT DISTILLING LLC	Assay, Impurities	Hand Sanitizer sampling and testing	Assay does not meet label claim but within efficacy range; Failed Impurities
Hand Sanitizer	NA	LIQUID	Montezuma Winery LLC	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Assay; Failed Impurities
Hand Sanitizer	NA	LIQUID	Montezuma Winery LLC	Assay, Impurities	Hand Sanitizer sampling and testing	Assay does not meet label claim but within efficacy range; Failed Impurities
Hand Sanitizer	NA	LIQUID	On Hand Lotions, LLC	Assay, Impurities	Hand Sanitizer sampling and testing	Assay does not meet label claim but within efficacy range; Failed Impurities
Hand Sanitizer	NA	LIQUID	The Hanson Group	Assay, Impurities	Hand Sanitizer sampling and testing	Assay does not meet label claim but within efficacy range; Failed Impurities
Hand Sanitizer	NA	LIQUID	Dancing Goat Distillery, LLC	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Assay; Failed Impurities
Hand Sanitizer	NA	LIQUID	Koval Inc.	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Assay; Failed Impurities
Hand Sanitizer	NA	LIQUID	Hans Manufacturer Inc.	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Tests
Hand Sanitizer	NA	LIQUID	Hans Manufacturer Inc.	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Tests
Hand Sanitizer	NA	LIQUID	Hans Manufacturer Inc.	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Tests
Hand Sanitizer	NA	LIQUID	Hans Manufacturer Inc.	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Tests
Hand Sanitizer	NA	LIQUID	Hans Manufacturer Inc.	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Tests
Hand Sanitizer	NA	LIQUID	Innova Supply, Inc.	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Assay; Failed Impurities
Hand Sanitizer	NA	GEL	CrudeChem Technology, LLC	Assay, Impurities, Microbial Enumeration Test and Tests for Specified Micro-Organisms	Hand Sanitizer sampling and testing	Assay does not meet label claim but within efficacy range; Failed Impurities, Passed Microbial Enumeration Test and Tests for Specified Micro-Organisms
Hand Sanitizer	NA	LIQUID	R&D Coatings, LLC	Assay, Impurities	Hand Sanitizer sampling and testing	Assay does not meet label claim but within efficacy range; Passed Impurities
Hand Sanitizer	NA	LIQUID	Alpha Aromatics	Assay, Impurities	Hand Sanitizer sampling and testing	Assay does not meet label claim but within efficacy range; Failed Impurities
Hand Sanitizer	NA	LIQUID	Quadex LLC	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Assay; Failed Impurities
Hand Sanitizer	NA	LIQUID	Quadex LLC	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Assay, Failed Impurities
Hand Sanitizer	NA	LIQUID	Salt Flats Spirits	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Assay; Failed Impurities
Hand Sanitizer	NA	LIQUID	Clear Lakes Products, LLC	Assay, Impurities	Hand Sanitizer sampling and testing	Assay does not meet label claim but within efficacy range; Passed Impurities
Hand Sanitizer	NA	LIQUID	Griffo Distillery	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Assay; Failed Impurities
Hand Sanitizer	NA	LIQUID	Garb2art Cosmetics	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Tests
Hand Sanitizer	NA	GEL	Marquis Energy, LLC	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Tests
Hand Sanitizer	NA	GEL	Marquis Energy, LLC	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Tests
Hand Sanitizer	NA	GEL	Marquis Energy, LLC	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Tests
Hand Sanitizer	NA	LIQUID	Hocking Technical College	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Assay; Failed Impurities
Hand Sanitizer	NA	LIQUID	Hocking Technical College	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Assay; Failed Impurities
Hand Sanitizer	NA	LIQUID	Hocking Technical College	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Assay; Failed Impurities
Hand Sanitizer	NA	LIQUID	Natuurs Direct LLC	Assay, Impurities	Hand Sanitizer sampling and testing	Assay does not meet label claim but within efficacy range; Failed Impurities
Hand Sanitizer	NA	LIQUID	Du Nord Craft Spirits	Assay, Impurities	Hand Sanitizer sampling and testing	Assay does not meet label claim but within efficacy range; Failed Impurities
Hand Sanitizer	NA	LIQUID	Du Nord Craft Spirits	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Assay; Failed Impurities
Hand Sanitizer	NA	LIQUID	Nanomaterials Discovery Corporation	Assay, Impurities	Hand Sanitizer sampling and testing	Assay does not meet label claim but within efficacy range; Failed Impurities
Hand Sanitizer	NA	LIQUID	Rock Town Distillery, Inc.	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Assay; Failed Impurities
Hand Sanitizer	NA	LIQUID	Atc Scientific, LLC	Assay, Impurities	Hand Sanitizer sampling and testing	Failed Tests
Hand Sanitizer	NA	LIQUID	Honeywell International Inc.	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Tests
Hand Sanitizer	NA	LIQUID	Honeywell International Inc.	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Tests
Hand Sanitizer	NA	LIQUID	Honeywell International Inc.	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Tests
Hand Sanitizer	NA	LIQUID	American Chemical Solutions LLC	Assay, Impurities	Hand Sanitizer sampling and testing	Assay does not meet label claim but within efficacy range; Failed Impurities
Hand Sanitizer	NA	LIQUID	American Chemical Solutions LLC	Assay, Impurities	Hand Sanitizer sampling and testing	Assay does not meet label claim but within efficacy range; Failed Impurities
Hand Sanitizer	NA	LIQUID	Haviland Products Company	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Assay; Failed Impurities
Hand Sanitizer	NA	LIQUID	Haviland Products Company	Assay, Impurities	Hand Sanitizer sampling and testing	Assay does not meet label claim but within efficacy range; Failed Impurities
Hand Sanitizer	NA	LIQUID	Long Road Distillers	Assay, Impurities	Hand Sanitizer sampling and testing	Assay does not meet label claim but within efficacy range; Failed Impurities
Hand Sanitizer	NA	GEL	Industry Supply Inc	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Tests
Hand Sanitizer	NA	LIQUID	Genesis Custom Chemical Blending	Assay, Impurities, Microbial Enumeration Test and Tests for Specified Micro-Organisms	Hand Sanitizer sampling and testing	Failed Assay, Passed Impurities, Passed Microbial Enumeration Test and Tests for Specified Micro-Organisms
Hand Sanitizer	NA	LIQUID	Backdrop Distilling	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Assay; Failed Impurities
Hand Sanitizer	NA	LIQUID	Maverick Spirit LLC	Assay, Impurities	Hand Sanitizer sampling and testing	Assay does not meet label claim but within efficacy range; Failed Impurities
Hand Sanitizer	NA	LIQUID	ST. JULIAN WINE COMPANY, INCORPORATE	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Assay; Failed Impurities
Hand Sanitizer	NA	LIQUID	ST. JULIAN WINE COMPANY, INCORPORATE	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Assay; Failed Impurities
Hand Sanitizer	NA	LIQUID	ST. JULIAN WINE COMPANY, INCORPORATE	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Assay; Failed Impurities
Hand Sanitizer	NA	LIQUID	Bioresource Technology Inc	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Tests
Hand Sanitizer	NA	LIQUID	JDSO INC	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Assay; Failed Impurities
Hand Sanitizer	NA	LIQUID	Foundry Distilling Company, LLC	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Assay; Failed Impurities
Hand Sanitizer	NA	LIQUID	Pernod Ricard USA, LLC	Assay, Impurities, Microbial Enumeration Test and Tests for Specified Micro-Organisms	Hand Sanitizer sampling and testing	Passed Assay, Failed Impurities; Passed Microbial Enumeration Test and Tests for Specified Micro-Organisms
Hand Sanitizer	NA	LIQUID	Humble Suds, LLC	Assay, Impurities, Microbial Enumeration Test and Tests for Specified Micro-Organisms	Hand Sanitizer sampling and testing	Passed Assay, Failed Impurities; Passed Microbial Enumeration Test and Tests for Specified Micro-Organisms
Hand Sanitizer	NA	LIQUID	Humble Suds, LLC	Assay, Impurities, Microbial Enumeration Test and Tests for Specified Micro-Organisms	Hand Sanitizer sampling and testing	Assay does not meet label claim but within efficacy range; Passed Impurities; Passed Microbial Enumeration Test and Tests for Specified Micro-Organisms
Hand Sanitizer	NA	LIQUID	GMG Investments, LLC	Assay, Impurities, Microbial Enumeration Test and Tests for Specified Micro-Organisms	Hand Sanitizer sampling and testing	Assay does not meet label claim but within efficacy range; Passed Impurities; Passed Microbial Enumeration Test and Tests for Specified Micro-Organisms
Hand Sanitizer	NA	LIQUID	Industrial Chemical Solutions, LLC	Assay, Impurities	Hand Sanitizer sampling and testing	Assay does not meet label claim but within efficacy range; Failed Impurities
Hand Sanitizer	NA	LIQUID	Porchjam Distillation	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Assay; Failed Impurities
Hand Sanitizer	NA	GEL	Santa Fe Distillery, LLC	Assay, Impurities	Hand Sanitizer sampling and testing	Assay does not meet label claim but within efficacy range; Failed Impurities
Hand Sanitizer	NA	GEL	SUN WAVE WELLNESS LLC	Assay, Impurities, Microbial Enumeration Test and Tests for Specified Micro-Organisms	Hand Sanitizer sampling and testing	Passed Assay, Failed Impurities; Passed Microbial Enumeration Test and Tests for Specified Micro-Organisms
Hand Sanitizer	NA	LIQUID	Innova4D USA CORP	Assay, Impurities	Hand Sanitizer sampling and testing	Assay does not meet label claim but within efficacy range; Failed Impurities
Hand Sanitizer	NA	LIQUID	Ublendit, LLC	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Assay; Failed Impurities
Hand Sanitizer	NA	LIQUID	Ublendit, LLC	Assay, Impurities	Hand Sanitizer sampling and testing	Assay does not meet label claim but within efficacy range; Failed Impurities
Hand Sanitizer	NA	LIQUID	Ublendit, LLC	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Assay; Failed Impurities
Hand Sanitizer	NA	LIQUID	The Lab LLC	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Assay; Failed Impurities
Hand Sanitizer	NA	LIQUID	J AND L DISTILLING COMPANY	Assay, Impurities, Microbial Enumeration Test and Tests for Specified Micro-Organisms	Hand Sanitizer sampling and testing	Passed Assay, Failed Impurities; Passed Microbial Enumeration Test and Tests for Specified Micro-Organisms
Hand Sanitizer	NA	LIQUID	Adam's Polishes LLC	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Assay; Failed Impurities
Hand Sanitizer	NA	LIQUID	Adam's Polishes LLC	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Tests
Hand Sanitizer	NA	LIQUID	Adam's Polishes LLC	Assay, Impurities	Hand Sanitizer sampling and testing	Failed Assay; Passed Impurities
Hand Sanitizer	NA	LIQUID	Prohibition Distillery LLC	Assay, Impurities	Hand Sanitizer sampling and testing	Assay does not meet label claim but within efficacy range; Failed Impurities
Hand Sanitizer	NA	LIQUID	Prohibition Distillery LLC	Assay, Impurities	Hand Sanitizer sampling and testing	Assay does not meet label claim but within efficacy range; Failed Impurities
Hand Sanitizer	NA	LIQUID	Nova Pressroom Products	Assay, Impurities	Hand Sanitizer sampling and testing	Assay does not meet label claim but within efficacy range; Failed Impurities
Hand Sanitizer	NA	LIQUID	Nova Pressroom Products	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Assay; Failed Impurities
Hand Sanitizer	NA	LIQUID	St. Augustine Distillery, LLC	Assay, Impurities	Hand Sanitizer sampling and testing	Assay does not meet label claim but within efficacy range; Failed Impurities
Hand Sanitizer	NA	LIQUID	OMI Industries	Assay, Impurities	Hand Sanitizer sampling and testing	Failed Tests
Hand Sanitizer	NA	LIQUID	Lucas Oil Racing, Inc.	Assay, Impurities	Hand Sanitizer sampling and testing	Assay does not meet label claim but within efficacy range; Failed Impurities
Hand Sanitizer	NA	LIQUID	Anchor Seal Inc	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Tests
Hand Sanitizer	NA	LIQUID	Vision Chemical Systems	Assay, Impurities	Hand Sanitizer sampling and testing	Assay does not meet label claim but within efficacy range; Passed Impurities
Hand Sanitizer	NA	LIQUID	Louisville Distilling Company, LLC	Assay, Impurities, Microbial Enumeration Test and Tests for Specified Micro-Organisms	Hand Sanitizer sampling and testing	Passed Assay, Failed Impurities; Passed Microbial Enumeration Test and Tests for Specified Micro-Organisms
Hand Sanitizer	NA	LIQUID	Barrel House Distilling Co.	Assay, Impurities	Hand Sanitizer sampling and testing	Assay does not meet label claim but within efficacy range; Failed Impurities
Hand Sanitizer	NA	LIQUID	Skip Rock Distillers	Assay, Impurities	Hand Sanitizer sampling and testing	Assay does not meet label claim but within efficacy range; Failed Impurities
Hand Sanitizer	NA	LIQUID	Skip Rock Distillers	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Assay; Failed Impurities
Hand Sanitizer	NA	LIQUID	Ademark Products, Inc.	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Tests
Hand Sanitizer	NA	LIQUID	Tennessee Technical Coatings, Corp.	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Assay; Failed Impurities
Hand Sanitizer	NA	LIQUID	Tenn South Distillery LLC dba Big Machine Distillery	Assay, Impurities	Hand Sanitizer sampling and testing	Assay does not meet label claim but within efficacy range; Failed Impurities
Hand Sanitizer	NA	LIQUID	SINGIN RIVER BREWING COMPANY	Assay, Impurities	Hand Sanitizer sampling and testing	Assay does not meet label claim but within efficacy range; Failed Impurities
Hand Sanitizer	NA	LIQUID	SINGIN RIVER BREWING COMPANY	Assay, Impurities	Hand Sanitizer sampling and testing	Assay does not meet label claim but within efficacy range; Failed Impurities
Hand Sanitizer	NA	LIQUID	Lucas Oil Racing, Inc.	Assay, Impurities	Hand Sanitizer sampling and testing	Assay does not meet label claim but within efficacy range; Failed Impurities
Hand Sanitizer	NA	LIQUID	Southampton Partners LLC	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Tests
Hand Sanitizer	NA	LIQUID	Southampton Partners LLC	Assay, Impurities	Hand Sanitizer sampling and testing	Failed Assay; Passed Impurities
Hand Sanitizer	NA	LIQUID	Hamilton Sundstrand Corporation	Assay, Impurities	Hand Sanitizer sampling and testing	Assay does not meet label claim but within efficacy range; Passed Impurities
Hand Sanitizer	NA	LIQUID	Hamilton Sundstrand Corporation	Assay, Impurities	Hand Sanitizer sampling and testing	Failed Tests
Hand Sanitizer	NA	LIQUID	Metro Group, Inc.	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Assay; Failed Impurities
Hand Sanitizer	NA	LIQUID	Altria Compounds	Assay, Impurities	Hand Sanitizer sampling and testing	Assay does not meet label claim but within efficacy range; Failed Impurities
Hand Sanitizer	NA	LIQUID	Blue Sky Distillery	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Assay; Failed Impurities
Hand Sanitizer	NA	GEL	PlasmaDent Inc	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Tests
Hand Sanitizer	NA	GEL	PlasmaDent Inc	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Tests
Hand Sanitizer	NA	LIQUID	Kilimanjaro Distillery LLC	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Assay; Failed Impurities
Hand Sanitizer	NA	LIQUID	Kilimanjaro Distillery LLC	Assay, Impurities	Hand Sanitizer sampling and testing	Assay does not meet label claim but within efficacy range; Failed Impurities
Hand Sanitizer	NA	LIQUID	Ghost Coast Distillery, LLC	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Assay; Failed Impurities
Hand Sanitizer	NA	LIQUID	Ghost Coast Distillery, LLC	Assay, Impurities	Hand Sanitizer sampling and testing	Assay does not meet label claim but within efficacy range; Failed Impurities
Hand Sanitizer	NA	LIQUID	Ghost Coast Distillery, LLC	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Assay; Failed Impurities
Hand Sanitizer	NA	LIQUID	OMI Industries	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Assay; Failed Impurities
Hand Sanitizer	NA	LIQUID	Jim Beam Brands Co.	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Assay; Failed Impurities
Hand Sanitizer	NA	LIQUID	Ancient Aromas LLC	Assay, Impurities	Hand Sanitizer sampling and testing	Assay does not meet label claim but within efficacy range; Failed Impurities
Hand Sanitizer	NA	LIQUID	Ancient Aromas LLC	Assay, Impurities	Hand Sanitizer sampling and testing	Assay does not meet label claim but within efficacy range; Failed Impurities
Hand Sanitizer	NA	LIQUID	Windsor Run Cellars	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Assay; Failed Impurities
Hand Sanitizer	NA	LIQUID	IWD Enterprises, LLC	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Assay; Failed Impurities
Hand Sanitizer	NA	LIQUID	TERRABOOST MEDIA LLC	Assay, Impurities	Hand Sanitizer sampling and testing	Assay does not meet label claim but within efficacy range; Passed Impurities
Hand Sanitizer	NA	LIQUID	TERRABOOST MEDIA LLC	Assay, Impurities	Hand Sanitizer sampling and testing	Assay does not meet label claim but within efficacy range; Passed Impurities
Hand Sanitizer	NA	LIQUID	Vanderbilt University	Assay, Impurities	Hand Sanitizer sampling and testing	Assay does not meet label claim but within efficacy range; Failed Impurities
Hand Sanitizer	NA	LIQUID	Badland Provision Co	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Assay; Failed Impurities
Hand Sanitizer	NA	LIQUID	Porchjam Distillation	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Assay; Failed Impurities
Hand Sanitizer	NA	LIQUID	Porchjam Distillation	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Assay; Failed Impurities
Hand Sanitizer	NA	LIQUID	HS BEVERAGE INC.	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Tests
Hand Sanitizer	NA	LIQUID	HS BEVERAGE INC.	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Assay; Failed Impurities
Hand Sanitizer	NA	LIQUID	Lula Restaurant Distillery	Assay, Impurities	Hand Sanitizer sampling and testing	Assay does not meet label claim but within efficacy range; Failed Impurities
Hand Sanitizer	NA	LIQUID	Hand Sanitizer LLC	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Assay; Failed Impurities
Hand Sanitizer	NA	LIQUID	Team Bg and Associates L.M.A., Inc.	Assay, Impurities	Hand Sanitizer sampling and testing	Assay does not meet label claim but within efficacy range; Failed Impurities
Hand Sanitizer	NA	LIQUID	NE Finest LLC	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Tests
Hand Sanitizer	NA	LIQUID	The Lab LLC	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Tests
Hand Sanitizer	NA	LIQUID	Balcones Distilling	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Assay, Failed Impurities
Hand Sanitizer	NA	LIQUID	Communications & Power Industries	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Tests
Hand Sanitizer	NA	LIQUID	Tiodize, Inc.	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Tests
Hand Sanitizer	NA	LIQUID	Cart/Horse Distilling	Assay, Impurities	Hand Sanitizer sampling and testing	Assay does not meet label claim but within efficacy range; Failed Impurities
Hand Sanitizer	NA	LIQUID	Backwards Distilling Company	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Assay; Failed Impurities
Hand Sanitizer	NA	LIQUID	Kolts Fine Spirits	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Assay; Failed Impurities
Hand Sanitizer	NA	LIQUID	Kolts Fine Spirits	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Assay; Failed Impurities
Hand Sanitizer	NA	LIQUID	R. R. Street & Co. Inc.	Assay, Impurities	Hand Sanitizer sampling and testing	Assay does not meet label claim but within efficacy range; Passed Impurities
Hand Sanitizer	NA	LIQUID	R. R. Street & Co. Inc.	Assay, Impurities	Hand Sanitizer sampling and testing	Assay does not meet label claim but within efficacy range; Passed Impurities
Hand Sanitizer	NA	LIQUID	R. R. Street & Co. Inc.	Assay, Impurities	Hand Sanitizer sampling and testing	Assay does not meet label claim but within efficacy range; Failed Impurities
Hand Sanitizer	NA	LIQUID	CREAGEN INC.	Assay, Impurities	Hand Sanitizer sampling and testing	Assay does not meet label claim but within efficacy range; Passed Impurities
Hand Sanitizer	NA	LIQUID	CREAGEN INC.	Assay, Impurities	Hand Sanitizer sampling and testing	Assay does not meet label claim but within efficacy range; Passed Impurities
Hand Sanitizer	NA	LIQUID	CREAGEN INC.	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Tests
Hand Sanitizer	NA	GEL	Printers Oil Supply Co., Inc	Assay, Impurities	Hand Sanitizer sampling and testing	Assay does not meet label claim but within efficacy range; Failed Impurities
Hand Sanitizer	NA	LIQUID	Team Bg and Associates L.M.A., Inc.	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Tests
Hand Sanitizer	NA	LIQUID	Jewel Dent	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Tests
Hand Sanitizer	NA	GEL	BASF Corporation	Assay, Impurities	Hand Sanitizer sampling and testing	Assay does not meet label claim but within efficacy range; Passed Impurities
Hand Sanitizer	NA	GEL	BASF Corporation	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Tests
Hand Sanitizer	NA	LIQUID	Red Brick Craft Distillery	Assay, Impurities	Hand Sanitizer sampling and testing	Assay does not meet label claim but within efficacy range; Failed Impurities
Hand Sanitizer	NA	LIQUID	Firestone and Robertson Distilling	Assay, Impurities, Microbial Enumeration Test and Tests for Specified Micro-Organisms	Hand Sanitizer sampling and testing	Passed Assay, Failed Impurities; Passed Microbial Enumeration Test and Tests for Specified Micro-Organisms
Hand Sanitizer	NA	LIQUID	Firestone and Robertson Distilling	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Assay; Failed Impurities
Hand Sanitizer	NA	LIQUID	Integrity Bio-Chemicals, LLC	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Assay; Failed Impurities
Hand Sanitizer	NA	LIQUID	Integrity Bio-Chemicals, LLC	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Assay; Failed Impurities
Hand Sanitizer	NA	LIQUID	Integrity Bio-Chemicals, LLC	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Assay; Failed Impurities
Hand Sanitizer	NA	LIQUID	Spinster Sisters, Inc.	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Tests
Hand Sanitizer	NA	LIQUID	Spinster Sisters, Inc.	Assay, Impurities	Hand Sanitizer sampling and testing	Assay does not meet label claim but within efficacy range; Passed Impurities
Hand Sanitizer	NA	LIQUID	Total Access Resources	Assay, Impurities	Hand Sanitizer sampling and testing	Assay does not meet label claim but within efficacy range; Passed Impurities
Hand Sanitizer	NA	LIQUID	NEVADA LABORATORIES & ANALYTICS INC.	Assay, Impurities	Hand Sanitizer sampling and testing	Assay does not meet label claim but within efficacy range; Failed Impurities
Hand Sanitizer	NA	LIQUID	WMC/PBD LLC	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Assay; Failed Impurities
Hand Sanitizer	NA	LIQUID	Kozuba & Sons Distillery Inc	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Assay; Failed Impurities
Hand Sanitizer	NA	LIQUID	Mossy Ledge Spirits	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Assay; Failed Impurities
Hand Sanitizer	Hyatt Life Sciences	LIQUID	Hyatt Life Sciences, Inc.	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Tests
Hand Sanitizer	OctoClenz Alcohol Antiseptic 80% Topical Solution	LIQUID	Octochem, Inc.	Assay, Impurities	Hand Sanitizer sampling and testing	Assay does not meet label claim but within efficacy range; Passed Impurities
Hand Sanitizer	Alcohol Antiseptic 80% Topical Solution Hand Sanitizer	LIQUID	Pernod Ricard USA, LLC	Assay, Impurities, Microbial Enumeration Test and Tests for Specified Micro-Organisms	Hand Sanitizer sampling and testing	Assay does not meet label claim but within efficacy range; Failed Impurities, Passed Microbial Enumeration Test and Tests for Specified Micro-Organisms
Hand Sanitizer	Drivergent Hand Sanitizer 80% Alcohol Antiseptic Topical Hand Rub	LIQUID	Drivergent, Inc.	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Assay; Failed Impurities
Hand Sanitizer	Drivergent Hand Sanitizer 80% Alcohol Antiseptic Topical Hand Rub	LIQUID	Drivergent, Inc.	Assay, Impurities	Hand Sanitizer sampling and testing	Assay does not meet label claim but within efficacy range; Failed Impurities
Hand Sanitizer	PFI Hand Sanitizer 80% Solution	LIQUID	Prengers Furniture Inc	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Assay; Failed Impurities
Hand Sanitizer	Alcohol Anitseptic "Hand Sanitizer 80% topical solution" OOLA	LIQUID	OOLA Industries dba OOLA Distillery	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Assay; Failed Impurities
Hand Sanitizer	Brewing Beltway Co. EST 2011 BREWING UP POSSIBILITIES HAND SANITIZER	LIQUID	Beltway Brewing Company	Assay, Impurities	Hand Sanitizer sampling and testing	Assay does not meet label claim but within efficacy range; Failed Impurities
Hand Sanitizer	Brewing Beltway Co. EST 2011 BREWING UP POSSIBILITIES HAND SANITIZER	LIQUID	Beltway Brewing Company	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Assay; Failed Impurities
Hand Sanitizer	Hand Sanitizer	LIQUID	WILDRYE DISTILLING, LLC	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Assay; Failed Impurities
Hand Sanitizer	State Line Distillery	LIQUID	State Line Distillery, LLC	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Assay; Failed Impurities
Hand Sanitizer	Raff Distillerie	LIQUID	Raff Beverage, LLC	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Assay; Failed Impurities
Hand Sanitizer	INSOLCORP HAND SANITIZER Alcohol Antiseptic 80% Topical Solution Non-Sterile Solution	LIQUID	Insolcorp, LLC	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Assay; Failed Impurities
Hand Sanitizer	NA	LIQUID	The Sherwin Williams Company	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Tests
Hand Sanitizer	IN OUR GRIT OUR GLORY HAND SANITIZER	LIQUID	Board of Regents of the University of Nebraska	Assay, Impurities	Hand Sanitizer sampling and testing	Assay does not meet label claim but within efficacy range; Failed Impurities
Hand Sanitizer	SIREtizer Hand Sanitizer	LIQUID	Southwest Iowa Renewbable Energy	Assay, Impurities	Hand Sanitizer sampling and testing	Failed Tests
Hand Sanitizer	SIREtizer Hand Sanitizer	LIQUID	Southwest Iowa Renewbable Energy	Assay, Impurities	Hand Sanitizer sampling and testing	Assay does not meet label claim but within efficacy range; Failed Impurities
Hand Sanitizer	SIREtizer Hand Sanitizer	LIQUID	Southwest Iowa Renewbable Energy	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Assay; Failed Impurities
Hand Sanitizer	CHAMPION 80 NON-STERILE SOLUTION HAND SANITIZER	LIQUID	Ridgecroft Distillery LLC	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Assay; Failed Impurities
Hand Sanitizer	Champion 80	LIQUID	Ridgecroft Distillery LLC	Assay, Impurities	Hand Sanitizer sampling and testing	Assay does not meet label claim but within efficacy range; Failed Impurities
Hand Sanitizer	Alcohol Antiseptic 80% Topical Solution	LIQUID	Kemin Industries, Inc.	Assay, Impurities	Hand Sanitizer sampling and testing	Assay was outside label claim but within efficacy range, Failed Impurities
Hand Sanitizer	Marquis XT Hand Sanitizer 70% Alcohol Gel Antiseptic	LIQUID	Bae Systems Land & Armaments L.P.	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Assay; Failed Impurities
Hand Sanitizer	Sapthre Maple Products Liquid Hand Sanitizer	LIQUID	Sapthre Maple Syrup	Assay, Impurities	Hand Sanitizer sampling and testing	Assay does not meet label claim but within efficacy range; Failed Impurities
Hand Sanitizer	EcoWerks Hand sanitizer	GEL	Bluebonnet Petrochemical Solutions	Assay, Impurities	Hand Sanitizer sampling and testing	Failed Tests
Hand Sanitizer	Salon Technologies International SANITIZING HAND SPRAY 80%	GEL	Salon Technologies International, Inc	Assay, Impurities, Microbial Enumeration Test and Tests for Specified Micro-Organisms	Hand Sanitizer sampling and testing	Assay does not meet label claim but within efficacy range; Failed Impurities, Passed Microbial Enumeration Test and Tests for Specified Micro-Organisms
Hand Sanitizer	NA	LIQUID	Khrysos Industries, Inc.	Assay, Impurities	Hand Sanitizer sampling and testing	Assay does not meet label claim but within efficacy range; Failed Impurities
Hand Sanitizer	Hand Sanitizer	LIQUID	Cerberus Craft Distillery LLC	Assay, Impurities	Hand Sanitizer sampling and testing	Assay does not meet label claim but within efficacy range; Failed Impurities
Hand Sanitizer	Alcohol Anitiseptic 80% - Topical Solution	LIQUID	Anchor Stillhouse Holdings LLC	Assay, Impurities	Hand Sanitizer sampling and testing	Assay does not meet label claim but within efficacy range; Failed Impurities
Hand Sanitizer	KUZE FUKU & SONS Alcohol Antiseptic 80 % Topical Solution Hand Sanitizer	LIQUID	St.Cousair, Inc.	Assay, Impurities	Hand Sanitizer sampling and testing	Assay does not meet label claim but within efficacy range; Failed Impurities
Hand Sanitizer	Hand-San Hand Sanitizer Alcohol Based	GEL	J & S Chemical Corporation	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Assay; Failed Impurities
Hand Sanitizer	WASHINGTON DISTILLERS GUILD ALCOHOL ANTISEPTIC 80% TOPICAL SOLUTION HAND SANITIZER	LIQUID	Scratch Distillery	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Assay; Failed Impurities
Hand Sanitizer	Vibra-tite 603	LIQUID	ND Industries, Inc.	Assay, Impurities	Hand Sanitizer sampling and testing	Assay does not meet label claim but within efficacy range; Passed Impurities
Hand Sanitizer	Vibra-tite 603	LIQUID	ND Industries, Inc.	Assay, Impurities	Hand Sanitizer sampling and testing	Assay does not meet label claim but within efficacy range; Passed Impurities
Hand Sanitizer	Alcohol Antiseptic 80% Topical Solution Hudson Whiskey	LIQUID	Tuthilltown Spirits LLC	Assay, Impurities	Hand Sanitizer sampling and testing	Assay does not meet label claim but within efficacy range; Failed Impurities
Hand Sanitizer	Alcohol Antiseptic 80% Topical Solution Hudson Whiskey	LIQUID	Tuthilltown Spirits LLC	Assay, Impurities	Hand Sanitizer sampling and testing	Assay does not meet label claim but within efficacy range; Failed Impurities
Hand Sanitizer	Alcohol Antiseptic 80% Topical Solution Hudson Whiskey	LIQUID	Tuthilltown Spirits LLC	Assay, Impurities	Hand Sanitizer sampling and testing	Assay does not meet label claim but within efficacy range; Failed Impurities
Hand Sanitizer	Alcohol Antiseptic 80% Topical Solution Antiseptic Hand Rub Saint-Gobain	LIQUID	Saint-Gobain Performance Plastics Corporation	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Assay; Failed Impurities
Hand Sanitizer	Alcohol Antiseptic 80% Topical Solution Antiseptic Hand Rub Saint-Gobain	LIQUID	Saint-Gobain Performance Plastics Corporation	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Assay; Failed Impurities
Hand Sanitizer	Sapthre Maple Products Liquid Hand Sanitizer	GEL	Sapthre Maple Syrup	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Assay; Failed Impurities
Hand Sanitizer	Hand Sanitizer	GEL	Dashfire	Assay, Impurities	Hand Sanitizer sampling and testing	Assay does not meet label claim but within efficacy range; Failed Impurities
Hand Sanitizer	Hand Sanitizer	GEL	Dashfire	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Assay; Failed Impurities
Hand Sanitizer	Isopropyl Alcohol Antiseptic 75% Topical Solution Hand Sanitizer	LIQUID	The Schwartz E-Liquid	Assay, Impurities	Hand Sanitizer sampling and testing	Assay does not meet label claim but within efficacy range; Passed Impurities
Hand Sanitizer	Isopropyl Alcohol Antiseptic 75% Topical Solution Hand Sanitizer	LIQUID	The Schwartz E-Liquid	Assay, Impurities	Hand Sanitizer sampling and testing	Assay does not meet label claim but within efficacy range; Passed Impurities
Hand Sanitizer	Isopropyl Alcohol Antiseptic 75% Topical Solution Hand Sanitizer	LIQUID	The Schwartz E-Liquid	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Tests
Hand Sanitizer	Coppercraft Distillery, Hand Sanitizer, Topical Solution, Alcohol Antiseptic 80%	LIQUID	Coppercraft Distillery LLC	Assay, Impurities	Hand Sanitizer sampling and testing	Assay does not meet label claim but within efficacy range; Failed Impurities
Hand Sanitizer	Coppercraft Distillery, Hand Sanitizer, Topical Solution, Alcohol Antiseptic 80%	LIQUID	Coppercraft Distillery LLC	Assay, Impurities	Hand Sanitizer sampling and testing	Assay does not meet label claim but within efficacy range; Failed Impurities
Hand Sanitizer	Journeyman Distillery Hand Sanitizer	LIQUID	Journeyman Distillery, LLC	Assay, Impurities	Hand Sanitizer sampling and testing	Assay does not meet label claim but within efficacy range; Failed Impurities
Hand Sanitizer	Journeyman Distillery Hand Sanitizer	LIQUID	Journeyman Distillery, LLC	Assay, Impurities	Hand Sanitizer sampling and testing	Assay does not meet label claim but within efficacy range; Failed Impurities
Hand Sanitizer	Sanctuary Spirits Hand Sanitizer	LIQUID	sanctuary spirits	Assay, Impurities	Hand Sanitizer sampling and testing	Assay does not meet label claim but within efficacy range; Failed Impurities
Hand Sanitizer	Sanctuary Spirits Hand Sanitizer	LIQUID	sanctuary spirits	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Assay; Failed Impurities
Hand Sanitizer	Sanctuary Spirits Hand Sanitizer	LIQUID	sanctuary spirits	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Assay, Failed Impurities
Hand Sanitizer	SAGAMORE SPIRIT HAND SANITIZER NON-STERILE SOLUTION	LIQUID	Sagamore Whiskey, LLC	Assay, Impurities	Hand Sanitizer sampling and testing	Assay does not meet label claim but within efficacy range; Failed Impurities
Hand Sanitizer	SANI-TIZE	LIQUID	Mark Andy Inc	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Tests
Hand Sanitizer	Dark Island Spirits	LIQUID	Dark Spirits Inc.	Assay, Impurities	Hand Sanitizer sampling and testing	Assay does not meet label claim but within efficacy range; Failed Impurities
Hand Sanitizer	Calwise Sprints Co Hand Sanitizer	LIQUID	Calwise Spirits Co.	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Assay; Failed Impurities
Hand Sanitizer	ohm by Urban Electric Power sanitizer spray	LIQUID	Urban Electric Power	Assay, Impurities	Hand Sanitizer sampling and testing	Assay does not meet label claim but within efficacy range; Failed Impurities
Hand Sanitizer	HAWAII TOPICAL SOLUTION HAND SANITIZER	LIQUID	Manulele Distillers, LLC	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Assay; Failed Impurities
Hand Sanitizer	SA-FE	LIQUID	Lola Vega Inc.	Assay, Impurities	Hand Sanitizer sampling and testing	Assay does not meet label claim but within efficacy range; Failed Impurities
Hand Sanitizer	Liquid Hand Sanitizer	LIQUID	Mohawk Laboratories Division	Assay, Impurities	Hand Sanitizer sampling and testing	Assay was outside label claim but within efficacy range.; Failed Impurities
Hand Sanitizer	Liquid Hand Sanitizer	LIQUID	Mohawk Laboratories Division	Assay, Impurities	Hand Sanitizer sampling and testing	Assay was outside label claim but within efficacy range.; Failed Impurities
Hand Sanitizer	Liquid Hand Sanitizer	LIQUID	Mohawk Laboratories Division	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Assay; Failed Assay
Hand Sanitizer	NA	LIQUID	STATLAB MEDICAL PRODUCTS	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Tests
Hand Sanitizer	Alcohol Antiseptic 80% Topical Solution	LIQUID	STATLAB MEDICAL PRODUCTS	Assay, Impurities	Hand Sanitizer sampling and testing	Assay does not meet label claim but within efficacy range; Failed Impurities
Hand Sanitizer	NA	LIQUID	STATLAB MEDICAL PRODUCTS	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Assay; Failed Impurities
Hand Sanitizer	Liquid Hand Sanitizer	LIQUID	United States Distilled Products	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Assay; Failed Impurities
Hand Sanitizer	New Alchemy Distilling	LIQUID	New Alchemy Distilling LLC	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Assay; Failed Impurities
Hand Sanitizer	New Alchemy Distilling	LIQUID	New Alchemy Distilling LLC	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Assay; Failed Impurities
Hand Sanitizer	Yellow Rose Distilling Hand Sanitizer	LIQUID	Yellow Rose Distilling	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Assay; Failed Impurities
Hand Sanitizer	Res-Cleanse Alcohol Antiseptic 80% Topical Solution	LIQUID	Res-Tek, Inc.	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Assay; Failed Impurities
Hand Sanitizer	William Price Distilling Company Hand Sanitizer	LIQUID	William Price Distilling Company	Assay, Impurities	Hand Sanitizer sampling and testing	Assay does not meet label claim but within efficacy range; Failed Impurities
Hand Sanitizer	William Price Distilling Company Hand Sanitizer	LIQUID	William Price Distilling Company	Assay, Impurities	Hand Sanitizer sampling and testing	Assay does not meet label claim but within efficacy range; Failed Impurities
Hand Sanitizer	William Price Distilling Company Hand Sanitizer	LIQUID	William Price Distilling Company	Assay, Impurities	Hand Sanitizer sampling and testing	Assay does not meet label claim but within efficacy range; Failed Impurities
Hand Sanitizer	GREENLEAF HAND SANITIZER	LIQUID	GMG Investments, LLC	Assay, Impurities, Microbial Enumeration Test and Tests for Specified Micro-Organisms	Hand Sanitizer sampling and testing	Passed Tests
Hand Sanitizer	RUBZAN Hand Gel Sanitizer	GEL	Prime Eco Group, Inc.	Assay, Impurities	Hand Sanitizer sampling and testing	Assay does not meet efficacy claim but within label claim; Failed Impurities
Hand Sanitizer	RUBZAN Hand Gel Sanitizer	GEL	Prime Eco Group, Inc.	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Assay; Failed Impurities
Hand Sanitizer	AFFEX CARE	GEL	Prime Eco Group, Inc.	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Tests
Hand Sanitizer	Walker Hand Sanitizer	GEL	Walker Emulsions Inc.	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Tests
Hand Sanitizer	Workman's Friend SUPERIOR HAND SANITIZER WITH ALOE AND CHAMOMILLEL	GEL	Packaging Service Co	Assay, Impurities, Microbial Enumeration Test and Tests for Specified Micro-Organisms	Hand Sanitizer sampling and testing	Passed Tests
Hand Sanitizer	Refrasia Care Hand Sanitizer	GEL	Lemon-X d.b.a. Bevolution Group	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Tests
Hand Sanitizer	Sanitiect Hand Sanitizer Ethyl Alcohol 65%	GEL	Pond Alliance, Inc	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Tests
Hand Sanitizer	Sanitiect Hand Sanitizer Ethyl Alcohol 65%	GEL	Pond Alliance, Inc	Assay, Impurities	Hand Sanitizer sampling and testing	Assay does not meet label claim but within efficacy range; Passed Impurities
Hand Sanitizer	Sanitiect Hand Sanitizer Ethyl Alcohol 65%	GEL	Pond Alliance, Inc	Assay, Impurities	Hand Sanitizer sampling and testing	Assay does not meet label claim but within efficacy range; Passed Impurities
Hand Sanitizer	ohm by Urban Electric Power hand sanitizer	GEL	Urban Electric Power	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Assay; Failed Impurities
Hand Sanitizer	ohm by Urban Electric Power hand sanitizer	GEL	Urban Electric Power	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Assay; Failed Impurities
Hand Sanitizer	ohm by Urban Electric Power hand sanitizer	GEL	Urban Electric Power	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Assay; Failed Impurities
Hand Sanitizer	NA	LIQUID	Beak & Skiff Apple Farms, Inc.	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Assay; Failed Impurities
Hand Sanitizer	NA	LIQUID	A.P. Nonweiler	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Assay; Failed Impurities
Hand Sanitizer	NA	LIQUID	Saint Lawrence Spirits,LLC	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Assay; Failed Impurities
Hand Sanitizer	NA	LIQUID	Mark Andy Inc	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Tests
Hand Sanitizer	NA	LIQUID	Koval Inc.	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Assay; Failed Impurities
Hand Sanitizer	NA	LIQUID	Koval Inc.	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Assay; Failed Impurities
Hand Sanitizer	NA	LIQUID	Journeyman Distillery, LLC	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Assay; Failed Impurities
Hand Sanitizer	NA	LIQUID	Coppercraft Distillery LLC	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Assay; Failed Impurities
Hand Sanitizer	NA	LIQUID	TCNY Products, LLC	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Tests
Hand Sanitizer	NA	LIQUID	Willamia Distilling	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Assay; Failed Impurities
Hand Sanitizer	NA	LIQUID	Xerox Corporation	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Assay; Failed Impurities
Hand Sanitizer	NA	LIQUID	Uncle Jumbo's Distillery Inc.	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Assay; Failed Impurities
Hand Sanitizer	NA	LIQUID	Doundrins Distilling	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Assay; Failed Impurities
Hand Sanitizer	NA	LIQUID	Khrysos Industries, Inc.	Assay, Impurities	Hand Sanitizer sampling and testing	Assay does not meet label claim but within efficacy range; Failed Impurities
Hand Sanitizer	NA	LIQUID	Khrysos Industries, Inc.	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Assay; Failed Impurities
Hand Sanitizer	NA	LIQUID	Salon Technologies International, Inc	Assay, Impurities, Microbial Enumeration Test and Tests for Specified Micro-Organisms	Hand Sanitizer sampling and testing	Assay does not meet label claim but within efficacy range; Passed Impurities; Passed Microbial Enumeration Test and Tests for Specified Micro-Organisms
Hand Sanitizer	NA	GEL	Bluebonnet Petrochemical Solutions	Assay, Impurities	Hand Sanitizer sampling and testing	Assay does not meet label claim but within efficacy range; Failed Impurities
Hand Sanitizer	NA	LIQUID	COPPER FOX DISTILLERY ENTERPRISES, L.L.C.	Assay, Impurities, Microbial Enumeration Test and Tests for Specified Micro-Organisms	Hand Sanitizer sampling and testing	Passed Assay, Failed Impurities; Passed Microbial Enumeration Test and Tests for Specified Micro-Organisms
Hand Sanitizer	NA	LIQUID	Ugly Dog Distillery, LLC	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Assay; Failed Impurities
Levetiracetam	NA	TABLET, EXTENDED RELEASE FILM COATED, USP	Apotex Inc.	Identification, Assay, Related Substances	Annual surveillance sampling and testing	Passed Tests
Niacin	NA	TABLET	Sun Pharmaceutical Industries Limited	Dissolution	Annual surveillance sampling and testing	Passed Test
Methylphenidate Hydrochloride	NA	TABLET, EXTENDED RELEASE	SpecGx LLC (Mallinckrodt, Inc.)	Identification, Content Uniformity, Dissolution, Organic Impurities, Water Content	Annual surveillance sampling and testing	Passed Tests
Methylphenidate Hydrochloride	NA	TABLET, EXTENDED RELEASE	Amneal Pharmaceuticals of New York, LLC	Identification, Content Uniformity, Dissolution, Organic Impurities, Water Content	Annual surveillance sampling and testing	Passed Tests
Diclofenac Sodium	NA	TABLET, DELAYED RELEASE, USP	CARLSBAD TECHNOLOGY INC	Identification, Assay, Content Uniformity, Dissolution, Impurities	Annual surveillance sampling and testing	Passed Tests
Glimepiride	NA	TABLET	CARLSBAD TECHNOLOGY INC	Identification, Assay, Content Uniformity, Dissolution, Impurities	Annual surveillance sampling and testing	Passed Tests
Acyclovir	NA	CAPSULE, USP	CARLSBAD TECHNOLOGY INC	Identification, Assay, Content Uniformity, Dissolution, Impurities	Annual surveillance sampling and testing	Passed Tests
Ciprofloxacin Hydrochloride	NA	TABLET	CARLSBAD TECHNOLOGY INC	Identification, Assay, Content Uniformity, Dissolution, Impurities	Annual surveillance sampling and testing	Passed Tests
Famotidine	NA	TABLET, USP	CARLSBAD TECHNOLOGY INC	Identification, Assay, Content Uniformity, Dissolution, Impurities	Annual surveillance sampling and testing	Passed Tests
Clonidine HCl	NA	TABLET, EXTENDED RELEASE	XIAMEN LP PHARMACEUTICAL CO., LTD.	Identification, Assay, Content Uniformity, Dissolution, Impurities	Import surveillance sampling and testing	Passed Tests
Clonidine HCl	NA	TABLET, EXTENDED RELEASE	LUPIN LIMITED	Identification, Assay, Dissolution	Import surveillance sampling and testing	Passed Tests
Dihydroergotamine Mesylate	NA	INJECTABLE, USP	JUBILANT HOLLISTERSTIER GENERAL PARTNERSHIP	Identification, Assay, pH, Bacterial Endotoxin	Import surveillance sampling and testing	Passed Tests
Tacrolimus	NA	CAPSULE, USP	Sandoz Private LTD	Identication, Assay, Dissolution, Impurities	Import surveillance sampling and testing	Passed Tests
Atomoxetine	NA	CAPSULE	Glenmark Pharmaceuticals Limited	Identification, Assay, Content Uniformity, Dissolution, Impurities	Import surveillance sampling and testing	Passed Tests
Heparin Sodium	NA	API	Bioiberica, SAU	Impurities	Heparin assignment	Passed Test
Crude Heparin	NA	CRUDE	Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd	Impurities	Heparin assignment	Passed Test
Crude Heparin	NA	CRUDE	Olymel S.E.C.	Impurities	Heparin assignment	Passed Test
Crude Heparin	NA	CRUDE	Maple Leaf Foods Inc	Impurities	Heparin assignment	Passed Test
Crude Heparin	NA	CRUDE HEPARIN ON RESIN BEADS	Sofina Foods	Impurities	Heparin assignment	Passed Test
Heparin Sodium	NA	PARENTERAL	Mylan Laboratories Limited, Speciality Formulation Facility	Impurities	Heparin assignment	Passed Test
Heparin Sodium	NA	PARENTERAL	Gland Pharma Limited	Impurities	Heparin assignment	Passed Test
Heparin Sodium	NA	PARENTERAL	Pfizer Healthcare India Private Limited	Impurities	Heparin assignment	Passed Test
Heparin Sodium	NA	PARENTERAL	Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd	Impurities	Heparin assignment	Passed Test
Heparin Sodium	NA	PARENTERAL	Pfizer Healthcare India Private Limited	Impurities	Heparin assignment	Passed Test
Heparin Sodium	NA	PARENTERAL	Biological E. Limited	Impurities	Heparin assignment	Passed Test
Insulin Lispro	Humalog	INJECTABLE	Eli Lilly	pH, Appearance, Assay, Impurities	MedWatch consumer complaint	Passed Tests
Dofetilide	NA	CAPSULE	Mayne Pharma, Inc.	Assay, Impurities, Content Uniformity	MedWatch consumer complaint	Passed Tests
Phenazopyridine HCl	NA	TABLET	GPT Pharmaceuticals Private Limited	Identification, Assay, Organic Impurities, Residual Solvents	Product on potential shortage list	Passed Tests
Morphine sulfate	NA	INJECTABLE	SSM Health Care	Identification, Assay, Economically motivated Adulteration	Opioid surveillance of compounding pharmacies	Passed Tests
Morphine sulfate	NA	INJECTABLE	Denver Solutions, LLC DBA Leiters Health	Identification, Assay, Economically motivated Adulteration	Opioid surveillance of compounding pharmacies	Passed Tests
Morphine sulfate	NA	INJECTABLE	Nephron Sterile Compounding Center LLC	Identification, Assay, Economically motivated Adulteration	Opioid surveillance of compounding pharmacies	Passed Tests
Morphine sulfate	NA	INJECTABLE	Brookfield Medical/Surgical Supply, Inc.	Identification, Assay, Economically motivated Adulteration	Opioid surveillance of compounding pharmacies	Passed Tests
Hydromorphone Chloride	NA	INJECTABLE	SSM Health Care	Identification, Assay, Economically motivated Adulteration	Opioid surveillance of compounding pharmacies	Passed Tests
Hydromorphone Chloride	NA	INJECTABLE	Denver Solutions, LLC DBA Leiters Health	Identification, Assay, Economically motivated Adulteration	Opioid surveillance of compounding pharmacies	Passed Tests
Hydromorphone Chloride	NA	INJECTABLE	Nephron Sterile Compounding Center LLC	Identification, Assay, Economically motivated Adulteration	Opioid surveillance of compounding pharmacies	Passed Tests
Fentanyl Citrate	NA	INJECTABLE	Denver Solutions, LLC DBA Leiters Health	Identification, Assay, Economically motivated Adulteration	Opioid surveillance of compounding pharmacies	Passed Tests
934 NF	Carbomer	EXCIPIENT	Lubrizol	Residual Solvents - benzene	Benzene contamination investigation of gel based hand sanitizers	Sample exceeded 2 ppm benzene; but, was within USP monograph limits.
934P NF	Carbomer	EXCIPIENT	Lubrizol	Residual Solvents - benzene	Benzene contamination investigation of gel based hand sanitizers	Sample exceeded 2 ppm benzene; but, was within USP monograph limits.
940 NF	Carbomer	EXCIPIENT	Lubrizol	Residual Solvents - benzene	Benzene contamination investigation of gel based hand sanitizers	Sample exceeded 2 ppm benzene; but, was within USP monograph limits.
941 NF	Carbomer	EXCIPIENT	Lubrizol	Residual Solvents - benzene	Benzene contamination investigation of gel based hand sanitizers	Sample exceeded 2 ppm benzene; but, was within USP monograph limits.
974P NF	Carbomer	EXCIPIENT	Lubrizol	Residual Solvents - benzene	Benzene contamination investigation of gel based hand sanitizers	Sample had less than 2 ppm benzene.
980 NF	Carbomer	EXCIPIENT	Lubrizol	Residual Solvents - benzene	Benzene contamination investigation of gel based hand sanitizers	Sample had less than 2 ppm benzene.
981 NF	Carbomer	EXCIPIENT	Lubrizol	Residual Solvents - benzene	Benzene contamination investigation of gel based hand sanitizers	Sample had less than 2 ppm benzene.
1342 NF	Carbomer	EXCIPIENT	Lubrizol	Residual Solvents - benzene	Benzene contamination investigation of gel based hand sanitizers	Sample exceeded 2 ppm benzene; but, was within USP monograph limits.
Phenazopyridine Hydrochloride	NA	API - In process blend	ATV Pharma Inc	Identification, Assay, Organic Impurities, Residual Solvents	Product on potential shortage list	Passed Identification, Assay, and Organic Impurities, Failed Residual Solvents
Hydrocortisone Acetate	NA	CREAM	Med Pride	Assay	Firm was not inspected and sent large volume of OTC to US. Distributor of drug products is on Import Alert list	Passed Test
Diltiazem Hydrochloride	NA	CAPSULE	Ingenus	Assay, Impurities, Content Uniformity, Dissolution	Adverse event reported to the FDA	Passed Test
Benzalkonium Chloride	Dr. Piercing AfterCare - Medication Filled Swabs	SWAB	Swabplus	Assay	Violations in test method practices and test method validation	Passed Test

FY 21 Results

Drug Name	Trade Name	Dosage Form	Firm	Tests Performed	Why Tested	Result
Albuterol Sulfate		INHALANT	Nephron Sterile Compounding Center LLC	Impurities, Leachables	Annual surveillance sampling and testing	Passed Test
BUPROPION HYDROCHLORIDE		TABLET, FILM COATED	Zhejiang Huahai Pharmaceutical Co., Ltd.	Content Uniformity, Dissolution, Identification, Impurities	Annual surveillance sampling and testing	Passed Test
CARBAMAZEPINE		TABLET, CHEWABLE	Torrent Pharma Inc.	Elemental Impurities	Annual surveillance sampling and testing	Passed Test
CISATRACURIUM BESYLATE		INJECTION	Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd.	Identificaton, Impurities, Assay	Annual surveillance sampling and testing	Passed Test
CISATRACURIUM BESYLATE		INJECTION	Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd.	Assay, Bacterial Endotoxins, Identification, pH, Organic Impurities	Annual surveillance sampling and testing	Passed Test
CLONIDINE HYDROCHLORIDE		TABLET	Xiamen LP Pharmaceutical Co., Ltd.	Assay, Content Uniformity, Dissolution, Identification, Related Substances	Annual surveillance sampling and testing	Passed Test
DOXYCYCLINE HYCLATE		TABLET	Zhejiang Huahai Pharmaceutical Co., Ltd.	Assay, Content Uniformity, Dissolution, Identification	Annual surveillance sampling and testing	Passed Test
EFAVIRENZ		TABLET, FILM COATED	Mylan Laboratories Limited	Assay, Content Uniformity, Dissolution, Identification, Organic Impurities	Annual surveillance sampling and testing	Passed Test
Hand Sanitizer		LIQUID	Pernod Ricard USA, LLC	Microbial Enumeration Test, Tests for Specified Micro-Organisms	Hand Sanitizer sampling and testing	Passed Test
Hand Sanitizer		LIQUID	OOLA Industries dba OOLA Distillery	Microbial Enumeration Test, Tests for Specified Micro-Organisms	Hand Sanitizer sampling and testing	Passed Test
Hand Sanitizer		LIQUID	Genesis Custom Chemical Blending	Microbial Enumeration Test, Tests for Specified Micro-Organisms	Hand Sanitizer sampling and testing	Passed Test
Hand Sanitizer	Pure Care	LIQUID	Alpha Aromatics	Microbial Enumeration Test, Tests for Specified Micro-Organisms	Hand Sanitizer sampling and testing	Passed Test
Hand Sanitizer	Indigeny Reserve Antiseptic Hand Rub	LIQUID	Indigeny Reserve	Microbial Enumeration Test, Tests for Specified Micro-Organisms	Hand Sanitizer sampling and testing	Passed Test
Hand Sanitizer	Frank-Lin Hand Sanitizer	LIQUID	Frank-Lin Distillers Products, Ltd.	Microbial Enumeration Test, Tests for Specified Micro-Organisms	Hand Sanitizer sampling and testing	Passed Test
Hand Sanitizer		LIQUID	Mayor Pharmaceutical Laboratories, Inc	Microbial Enumeration Test, Tests for Specified Micro-Organisms	Hand Sanitizer sampling and testing	Passed Test
Hand Sanitizer	Crude Chem Hand Sanitizer	LIQUID	CrudeChem Technology, LLC	Microbial Enumeration Test, Tests for Specified Micro-Organisms	Hand Sanitizer sampling and testing	Passed Test
Hand Sanitizer		LIQUID	QUEST INDUSTRIAL	Microbial Enumeration Test, Tests for Specified Micro-Organisms	Hand Sanitizer sampling and testing	Passed Test
Hand Sanitizer		LIQUID	COPPER FOX DISTILLERY ENTERPRISE	Microbial Enumeration Test, Tests for Specified Micro-Organisms	Hand Sanitizer sampling and testing	Passed Test
Hand Sanitizer		LIQUID	Salon Technologies International Inc	Microbial Enumeration Test, Tests for Specified Micro-Organisms	Hand Sanitizer sampling and testing	Passed Test
Hand Sanitizer		LIQUID	Pernod Ricard USA, LLC	Microbial Enumeration Test, Tests for Specified Micro-Organisms	Hand Sanitizer sampling and testing	Passed Test
Hand Sanitizer	COMFORT & MERCY HAND SANITIZER	LIQUID	Bottle Tree Beverage Company dba Cathead Distillery	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Assay; Failed Impurities
Hand Sanitizer	Humble Suds	LIQUID	Humble Suds, LLC	Assay, Impurities, Microbial Enumeration Test, Tests for Specified Micro-Organisms	Hand Sanitizer sampling and testing	Passed Assay; Failed Impurities
Hand Sanitizer	Sneaky Clean Hand Sanitizer Alcohol Antiseptic 80%	LIQUID	JDSO INC	Microbial Enumeration Test, Tests for Specified Micro-Organisms	Hand Sanitizer sampling and testing	Passed Test
Hand Sanitizer	Btec	LIQUID	North Carolina State University	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Test
Hand Sanitizer	Hand Sanitizer- Brenntag	LIQUID	Brenntag Southwest, Inc	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Assay; Failed Impurities
Hand Sanitizer	Torco Racing Fuels Hand Sanitizer (High Priority Testing)	LIQUID	Torco Race Fuels	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Assay; Failed Impurities
Hand Sanitizer		LIQUID	Hyatt Life Sciences	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Test
Hand Sanitizer		LIQUID	RYAN FLAVORS LLC	Assay, Impurities, Microbial Enumeration Test, Tests for Specified Micro-Organisms	Hand Sanitizer sampling and testing	Passed Test
Hand Sanitizer		LIQUID	Trans Chemical Inc	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Test
Hand Sanitizer	Cardinal Spirits Hand Sanitizer 80% ALCOHOL	LIQUID	Cardinal Spirits	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Test
Hand Sanitizer		LIQUID	One Ethanol LLC	Microbial Enumeration Test, Tests for Specified Micro-Organisms	Hand Sanitizer sampling and testing	Passed Test
Hand Sanitizer		LIQUID	Willamia Distilling	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Assay; Failed Impurities
Hand Sanitizer		LIQUID	Jarman's Midwest Cleaning System Inc	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Assay; Failed Impurities
Hand Sanitizer		LIQUID	Beak & Skiff Cider Mill, Inc.	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Assay; Failed Impurities
Hand Sanitizer		LIQUID	Pepsi-Cola Sales and Distribution, Inc.	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Test
Hand Sanitizer		LIQUID	Pond Alliance Inc	Microbial Enumeration Test, Tests for Specified Micro-Organisms	Hand Sanitizer sampling and testing	Passed Test
Hand Sanitizer		LIQUID	Sagamore Whiskey LLC	Microbial Enumeration Test, Tests for Specified Micro-Organisms	Hand Sanitizer sampling and testing	Passed Test
Hand Sanitizer		LIQUID	Atc Scientific LLC	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Impurities; Failed Assay
Hand Sanitizer	Fast-Tizer Hand Sanitizer	LIQUID	Fast-Tizer	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Test
Hand Sanitizer	GREENLEAF HAND SANITIZER	LIQUID	GMG Investments, LLC	Microbial Enumeration Test, Tests for Specified Micro-Organisms	Hand Sanitizer sampling and testing	Passed Test
Hand Sanitizer		LIQUID	Stockmeier Urethanes Inc.	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Test
Hand Sanitizer	Tara Materials Inc. Isopropyl Alcohol Antiseptic 75% Hand Sanitizer	LIQUID	Tara Materials Inc	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Test
Hand Sanitizer		LIQUID	Beltway Brewing Company	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Test
Hand Sanitizer		LIQUID	TCNY Products LLC	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Test
Hand Sanitizer	Ultra Optics	LIQUID	The Walman Optical Co	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Test
Hand Sanitizer	TEGO 2020 Isopropyl Alcohol Antiseptic 75% Topical Solution Hand Sanitizer	LIQUID	Evonik Corporation	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Test
Hand Sanitizer	Falcon Hand Sanitizer	LIQUID	Falcon Distributors	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Test
Hand Sanitizer		LIQUID	Firestone and Robertson Distilling	Microbial Enumeration Test, Tests for Specified Micro-Organisms	Hand Sanitizer sampling and testing	Passed Test
Hand Sanitizer	Workman's Friend SUPERIOR HAND SANITIZER WITH ALOE AND CHAMOMILLEL	GEL	Packaging Service Co	Microbial Enumeration Test, Tests for Specified Micro-Organisms	Hand Sanitizer sampling and testing	Passed Test
Hand Sanitizer	OctoClenz Alcohol Antiseptic 80% Topical Solution	LIQUID	Octochem, Inc.	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Test
Hand Sanitizer		LIQUID	The Sherwin Williams Company	Assay, Impurities	Hand Sanitizer sampling and testing	Passed Test
Hand Sanitizer		LIQUID	Froggy's Fog LLC	Assay, Impurities, Microbial Enumeration Test, Tests for Specified Micro-Organisms	Hand Sanitizer sampling and testing	Failed Assay and Impurities
HEPARIN SODIUM		INJECTION	Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd.	Impurities, Sterility, Bacterial Endotoxins, Particulate Matter	Annual surveillance sampling and testing	Passed Test
HEPARIN SODIUM		INJECTION	Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd.	Impurities, Sterility, Bacterial Endotoxins, Particulate Matter	Annual surveillance sampling and testing	Passed Test
Imatinib Mesylate		TABLET, FILM COATED	Mylan LLC	Assay, Content Uniformity, Dissolution, Elemental Impurities, Organic Impurities, Identification	Annual surveillance sampling and testing	Passed Test
LAMOTRIGINE		TABLET	CAPS CANADA US C/O PAR PHARMACEU	Content Uniformity, Dissolution, Identification, Organic Impurities	Annual surveillance sampling and testing	Passed Test
LAMOTRIGINE		TABLET	Zhejiang Huahai Pharmaceutical Co., Ltd.	Content Uniformity, Dissolution, Identification, Impurities	Annual surveillance sampling and testing	Passed Test
LITHIUM CARBONATE		TABLET	Mylan Laboratories Limited	Tablet Friability, Hardness	Annual surveillance sampling and testing	Passed Test
METHYLPHENIDATE HYDROCHLORIDE		Tablet, Chewable	Ascent Pharmaceuticals, Inc.	Content Uniformity, Dissolution, Identification, Organic Impurities, Water Content	Annual surveillance sampling and testing	Passed Test
MOMETASONE FUROATE		SPRAY, METERED	Sandoz Inc	Assay, Identification, Degradation Products	Annual surveillance sampling and testing	Passed Test
PHENYLEPHRINE HYDROCHLORIDE		INJECTION	Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd.	Assay, Identification	Annual surveillance sampling and testing	Passed Test
PHENYLEPHRINE HYDROCHLORIDE		INJECTION	Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd.	Microbial Enumeration Test, Tests for Specified Micro-Organisms	Annual surveillance sampling and testing	Passed Test
PILOCARPINE HYDROCHLORIDE		LIQUID	Akorn, Inc.	Assay, Microbial Enumeration Test, Tests for Specified Micro-Organisms, pH	Annual surveillance sampling and testing	Passed Test
TACROLIMUS		CAPSULE	Intas Pharmaceuticals Limited	Assay, Organic Impurities	Annual surveillance sampling and testing	Passed Test
GABAPENTIN		CAPSULE	TAGI Pharma, Inc.	Content Uniformity, Dissolution, Organic Impurities, Identification	Annual surveillance sampling and testing	Passed Test
ENOXAPARIN SODIUM		INJECTION	Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd.	Impurities, Sterility, Bacterial Endotoxins, Particulate Matter	Annual surveillance sampling and testing	Passed Test
ENOXAPARIN SODIUM		INJECTION	Northstar Rx Llc	Impurities, Sterility, Bacterial Endotoxins, Particulate Matter	Annual surveillance sampling and testing	Passed Test
DOXYCYCLINE			Solco Healtcare US LLC	Impurities, Identification	Annual surveillance sampling and testing	Passed Test
BUPROPION			Solco Healtcare US LLC	Identication, Content Uniformity, Organic Impurities, Dissolution	Annual surveillance sampling and testing	Passed Test
LITHIUM CARBONATE		TABLET	Mylan Pharmaceuticals Inc.	Friability, Hardness	Annual surveillance sampling and testing	Passed Test
EFAVIRENZ		TABLET	Mylan Pharmaceuticals Inc.	Assay, Dissolution, Content Uniformity, Identification, Organic Impurities	Annual surveillance sampling and testing	Passed Test
Pilocarpine Hydrochloride		SOLUTION	Akorn, Inc.	Assay, Identification, pH	Annual surveillance sampling and testing	Passed Test
ACYCLOVIR		TABLET	Carlsbad Technology, Inc	Assay, Dissolution, Content Uniformity, Identification, Impurities	Annual surveillance sampling and testing	Passed Test
CIPROFLOXACIN HCL		TABLET	Carlsbad Technology, Inc	Assay, Dissolution, Organic Impurities	Annual surveillance sampling and testing	Passed Test
FAMOTIDINE		TABLET, FILM COATED	Carlsbad Technology, Inc	Assay, Dissolution, Content Uniformity, Identification, Impurities	Annual surveillance sampling and testing	Passed Test
Hand Sanitizer	Pacific Coast Spirits	LIQUID	Hammond & Co, Inc.	Assay, Identification, Impurities, Methanol	For-Cause sampling and testing	Passed Methanol and Identification; Failed Assay and Impurities
Hand Sanitizer	H2One	GEL	No Manufacturing firm listed in FACTS. Dealer;Distributor: Global Sanitizers LLC; SAMARIAN PRODUCTS LLC	Assay, Identification	For-Cause sampling and testing	4 lots passed; 1 lot failed Assay
Hand Sanitizer		GEL	No Manufacturing firm listed in FACTS. Dealer;Distributor: Global Sanitizers LLC; SBL Brands, LLC. Collection Remarks (FACTS) states,"...Firm management at Global Sanitizers, LLC did not know the manufacturer of this product."	Assay, Identification, Impurities, Methanol	For-Cause sampling and testing	2 lots passed; 2 lots failed Assay; 1 lot failed Impurities
Hand Sanitizer		GEL	RNA Corporation	Assay, Identification, Impurities, Methanol	For-Cause sampling and testing	Passed Test
Hand Sanitizer		GEL	Ampak Chemicals Incorporated	Assay, Identification, Impurities, Methanol	For-Cause sampling and testing	5 lots passed; 1 lot failed Assay
Hand Sanitizer	Moxe Citrus Hand Sanitizer	GEL	JVL Laboratories Inc	Assay, Identification, Impurities, Methanol	For-Cause sampling and testing	Passed Assay, Methanol and Identification; Failed Impurities
Hand Sanitizer	DiBar Labs	GEL	Dibar Nutricional S. de R.L. de C.V.	Assay, Identification, Impurities	For-Cause sampling and testing	Passed Identification and Impurities; Failed Assay
Hand Sanitizer	the CREME Shop	GEL	The Creme Shop	Assay, Identification, Impurities, Methanol	For-Cause sampling and testing	Passed Assay, Methanol and Identification; Failed Impurities
Hand Sanitizer	Premium Nature Hand Sanitizer	GEL	PREMIUM NATURE	Assay, Impurities	For-Cause sampling and testing	Failed Test
Hand Sanitizer		GEL	Charles Paint Research Inc	Assay, Identification, Impurities	For-Cause sampling and testing	Passed Assay and Identification; Failed Impurities
Hand Sanitizer	HDX Hand Sanitizer Gel	GEL	JVL Laboratories Inc	Assay, Identification, Impurities, Methanol	For-Cause sampling and testing	Passed Test
Hand Sanitizer	Simply 70 Hand Sanitizer Gel	GEL	Froggy's Fog LLC	Assay, Identication, Impurities	For-Cause sampling and testing	Passed Identification and Impurities; Failed Assay
Propofol		Injection Emulsion	Fresenius Kabi Usa	Assay, Identification, pH	Drug Shortage	Passed Test
Acetazolamide		Injection	Mylan	Assay, Impurity	Citizen Petition	Passed Test
Acetazolamide		Injection	Hikma Pharmaceutical	Assay, Impurity	Citizen Petition	Passed Test
Adderall		Tablet	nextdaytablet.com	Identification, Assay, Impurities	Identify counterfeit products from online drug suppliers	Failed Identification and Assay
Adderall		Tablet	next2you.us	Identification, Assay, Impurities	Identify counterfeit products from online drug suppliers	Failed Identification and Assay
Rifampin		Injection	Fresenius Kabi	Impurities, Assay, Nitrosamine Screen	For-Cause investigation	Passed Test
Naloxone HCl		Injectable	International Medication Systems Ltd	Assay	Opioid surveillance	Passed Test
Buprenorphine HCl		Tablets	Purdue Pharmaceuticals Lp	Assay	Opioid surveillance	Passed Test
Buprenorphine HCl		Tablets	Hikma	Assay	Opioid surveillance	Passed Test
Buprenorphine/Naloxone		Tablets	Hikma	Assay	Opioid surveillance	Passed Test
Buprenorphine/Naloxone		Tablets	LTS Lohmann Therapy Systems Corp	Assay	Opioid surveillance	Passed Test
Buprenorphine/Naloxone		Tablets	Alcami Carolinas Corporation	Assay	Opioid surveillance	Passed Test
Buprenorphine/Naloxone		Tablets	Amneal Pharmaceuticals, Inc	Assay	Opioid surveillance	Passed Test
Buprenorphine/Naloxone		Tablets	SpecGx, LLC	Assay	Opioid surveillance	Passed Test
Naltrexone		Tablets	SpecGx, LLC	Assay	Opioid surveillance	Passed Test
Tramadol HCl		Tablets	Amneal Pharmaceuticals of New York	Assay	Opioid surveillance	Passed Test
Tramadol HCl		Tablets	Halo Pharmaceutical, Inc	Assay	Opioid surveillance	Passed Test
Methadone HCl		Tablets	Hikma	Assay	Opioid surveillance	Passed Test
Methadone HCl		Tablets	Elite Laboratories Inc	Assay	Opioid surveillance	Passed Test
Methadone HCl		Tablets	Aurolife Pharma, LLC	Assay	Opioid surveillance	Passed Test
Methadone HCl		Tablets	SpecGx, LLC	Assay	Opioid surveillance	Passed Test
Morphine sulfate		Injectable	International Medication Systems Ltd	Assay	Opioid surveillance	Passed Test
Fentanyl Citrate		Tablets, ODT	Pharmaceutics International Inc,	Assay	Opioid surveillance	Passed Test
Fentanyl Citrate		Tablets	Anesta LLC	Assay	Opioid surveillance	Passed Test
Fentanyl Citrate		Lozenge	Anesta LLC	Assay	Opioid surveillance	Passed Test
Morphine Sulfate		Tincture	Sovereign Pharmaceuticals, LLC	Assay	Opioid surveillance	Passed Test
Hydrocodone Bitartrate / Acetaminophen		Tablets	Novel Laboratories, Inc	Assay	Opioid surveillance	Passed Test
Hydrocodone Bitartrate / Acetaminophen		Oral Solution	Pharmaceutical Associates Inc	Assay	Opioid surveillance	Passed Test
Hydrocodone Bitartrate / Acetaminophen		Tablets	Halo Pharmaceutical, Inc	Assay	Opioid surveillance	Passed Test
Intimate Disinfection Spray		Spray	Kadesh	Elemental Analysis	For-Cause investigation	Failed Test
Puriton Skin Protectant		Topical	Kadesh	Elemental Analysis	For-Cause investigation	Failed Test
Facial Skin Protectant and Acne Treatment		Topical	Kadesh	Elemental Analysis	For-Cause investigation	Failed Test
First Aid Antiseptic and Antibiotic		Topical	Kadesh	Elemental Analysis	For-Cause investigation	Failed Test
Hand Sanitizier		Gel	Artnatural	Assay, Impurity	Citizen Petition	2 lots passed; 1 lot failed Assay and Impurity
Hand Sanitizier		Gel	The Creme Shop Peppermint Scented	Assay, Impurity	Citizen Petition	Failed Impurity
Hand Sanitizier		Gel	Star Wars Mandalorian	Assay, Impurity	Citizen Petition	1 lot failed Assay; 2 lots failed Impurity
Hand Sanitizier		Gel	Mickey Mouse	Assay, Impurity	Citizen Petition	Failed Impurity
Hand Sanitizier		Gel	Cala	Assay, Impurity	Citizen Petition	Failed Impurity
Hand Sanitizier		Gel	The Skinny	Assay, Impurity	Citizen Petition	Failed Impurity
Hand Sanitizier		Gel	HAND-SAN	Assay, Impurity	Citizen Petition	Failed Impurity
Hand Sanitizier		Gel	Body Prescriptions	Assay, Impurity	Citizen Petition	Failed Assay and Impurity
Hand Sanitizier		Gel	Born Basic	Assay, Impurity	Citizen Petition	Failed Impurity
Hand Sanitizier		Gel	Miami Carry On	Assay, Impurity	Citizen Petition	Failed Impurity
Hand Sanitizier		Gel	Natural Wunderz	Assay, Impurity	Citizen Petition	Failed Impurity
Hand Sanitizier		Gel	huangjisoo	Assay, Impurity	Citizen Petition	Failed Impurity
Hand Sanitizier		Gel	i-Softto	Assay, Impurity	Citizen Petition	Passed Test
Hand Sanitizier		Gel	Smart Care	Assay, Impurity	Citizen Petition	Passed Test
Hand Sanitizier		Gel	Defender+	Assay, Impurity	Citizen Petition	Passed Test
Hand Sanitizier		Gel	Frida	Assay, Impurity	Citizen Petition	Passed Test

FY 20 Results

Drug Name	Trade Name	Dosage Form	Firm	Tests Performed	Why Tested	Result
DOFETILIDE	Tikosyn	CAPSULE	Pfizer Pharmaceuticals LLC	Assay, Content Uniformity, Dissolution, Identification	Annual surveillance sampling and testing	Passed Test
LAMOTRIGINE	Generic	Tablet	Dr. Reddy's Laboratories Ltd.	Content Uniformity	Annual surveillance sampling and testing	Passed Test
LAMOTRIGINE	Generic	Tablet	Zhejiang Huahai Pharmaceutical Co., Ltd.	Content Uniformity, Dissolution, Identification, Impurities	Import surveillance sampling and testing	Passed Test
METFORMIN HYDROCHLORIDE	Generic	Tablet	Qingdao BAHEAL Pharmaceutical Co.,Ltd.	Assay, Content Uniformity, Dissolution, Identification, Impurities	Annual surveillance sampling and testing	Passed Test
METFORMIN HYDROCHLORIDE	Generic	Tablet, Film Coated	Actavis Laboratories FL, Inc.	Assay, Content Uniformity, Dissolution, Identification, Impurities	Annual surveillance sampling and testing	Passed Test
GLATIRAMER ACETATE	Generic	INJECTION	Ajinomoto Althea, Inc.	Assay, Microbials, Acetate Content, Identification, Peptide Concentration, pH, Impurities	Annual surveillance sampling and testing	Passed Test
GLATIRAMER ACETATE	Generic	INJECTION	Hospira Inc	Assay, Microbials, Acetate Content, Identification, Peptide Concentration, pH, Impurities	Annual surveillance sampling and testing	Passed Test
METHYLPHENIDATE HYDROCHLORIDE	Generic	Tablet	Amneal Pharmaceuticals of New York, LLC	Content Uniformity, Dissolution, Identification, Water Determination, Impurities	Annual surveillance sampling and testing	Passed Test
METHYLPHENIDATE HYDROCHLORIDE	Generic	Tablet, Film Coated	Amneal Pharmaceuticals of New York, LLC	Content Uniformity, Dissolution, Identification, Water Determination, Impurities	Annual surveillance sampling and testing	Passed Test
METHYLPHENIDATE HYDROCHLORIDE	Generic	Tablet	SpecGx, LLC	Content Uniformity, Dissolution, Identification, Impurities, Water Determination	Annual surveillance sampling and testing	Passed Test
METHYLPHENIDATE HYDROCHLORIDE	Generic	Tablet, Film Coated	SpecGx, LLC	Assay, Content Uniformity, Dissolution, Identification, Water Determination, Impurities	Annual surveillance sampling and testing	Passed Test
METHYLPHENIDATE HYDROCHLORIDE	Quillichew ER	Tablet	Tris Pharma Inc.	Content Uniformity, Dissolution, Identification, Impurities	Annual surveillance sampling and testing	Passed Test
TACROLIMUS	Generic	CAPSULE	Intas Pharmaceuticals Limited	Assay, Dissolution, Identification, Impurities	Annual surveillance sampling and testing	Passed Test
ACETYLCYSTEINE	Generic	INJECTION, SOLUTION	MYLAN LABORATORIES LTD	Assay, Microbials, Identification	Annual surveillance sampling and testing	Passed Test
VIGABATRIN	Generic	POWDER	Amneal Pharmaceuticals of New York, LLC	Assay, Content Uniformity, Identification, Impurities	Annual surveillance sampling and testing	Passed Test
VIGABATRIN	Sabril	POWDER	Patheon Pharmaceuticals Inc	Assay, Content Uniformity, Identification, Impurities	Annual surveillance sampling and testing	Passed Test
GABAPENTIN	Generic	CAPSULE	CSPC Ouyi Pharmaceutical Co., Ltd.	Assay, Content Uniformity, Dissolution, Impurities	Import surveillance sampling and testing	Passed Test
GABAPENTIN	Generic	TABLET	CSPC Ouyi Pharmaceutical Co., Ltd.	Assay, Content Uniformity, Dissolution, Impurities	Import surveillance sampling and testing	Passed Test
ACYCLOVIR	Generic	CAPSULE	Carlsbad Technology, Inc	Assay, Content Uniformity, Dissolution, Identification, Impurities	Annual surveillance sampling and testing	Passed Test
ACYCLOVIR	Generic	TABLET	Carlsbad Technology, Inc	Assay, Content Uniformity, Dissolution, Identification, Impurities, Weight Variation	Annual surveillance sampling and testing	Passed Test
BENZALKONIUM CHLORIDE	Generic	SPRAY, METERED	MSD International GmbH (Singapore Branch)	Assay, Sterility, Microbials, Identification	Annual surveillance sampling and testing	Passed Test
DICLOFENAC SODIUM	Generic	GEL	Tolmar, Inc.	Assay, Microbials, Alcohol Content, Identification, Limit of Benzaldehyde, Minimum Fill, pH, Impurities, Elemental Impurities	Annual surveillance sampling and testing	Passed Test
GANCICLOVIR SODIUM	Generic	INJECTION	Pharmascience Inc.	Assay, Microbials, Identification, Impurities	Annual surveillance sampling and testing	Passed Test
GLIMEPIRIDE	Generic	TABLET	Carlsbad Technology, Inc	Assay, Content Uniformity, Dissolution, Identification, Impurities	Annual surveillance sampling and testing	Passed Test
Hand Sanitizer (Ethanol Alcohol)	Rapid-A	LIQUID	NE Finest LLC	Assay, Impurities	Hand Sanitizer sampling & testing	Passed Test
Hand Sanitizer (Ethanol Alcohol)	tazza-x Extreme 70% alcohol formula	LIQUID	TERRABOOST MEDIA LLC	Assay, Impurities	Hand Sanitizer sampling & testing	Passed Test
Hand Sanitizer (Ethanol Alcohol)		LIQUID	Ambrosia Fragance	Assay, Impurities	Hand Sanitizer sampling & testing	Passed Test
Hand Sanitizer (Ethanol Alcohol)		LIQUID	The Metro Group Inc	Assay, Impurities	Hand Sanitizer sampling & testing	Passed Assay; Failed Impurities
Hand Sanitizer (Ethanol Alcohol)		LIQUID	North Shore Distillery	Assay, Impurities	Hand Sanitizer sampling & testing	Passed Test
Hand Sanitizer (Ethanol Alcohol)	Snosan hand sanitizer	GEL	J & L Distilling Company	Microbial Enumeration	Hand Sanitizer sampling & testing	Passed Test
Hand Sanitizer (Ethanol Alcohol)	HYE RUM Hye Yands High Proof Hand Wash	LIQUID	Ruminate Distilling dba Hye Rum	Assay, Impurities	Hand Sanitizer sampling & testing	Failed Assay and Impurities
Hand Sanitizer (Ethanol Alcohol)	SUN-LITE HAND SANITIZER with CITRUS	LIQUID	SUN LIQUOR MFG INC	Assay, Impurities	Hand Sanitizer sampling & testing	Passed Test
Hand Sanitizer (ISOPROPANOL ALCOHOL)	HandClasp Isopropyl Alcohol Antiseptic 75% Topical Solution Hand Sanitizer Non-sterile Solution	LIQUID	BASF Corporation	Assay, Impurities	Hand Sanitizer sampling & testing	Passed Test
Hand Sanitizer (ISOPROPANOL ALCOHOL)		LIQUID	Fisher Scientific Co., LLC	Assay, Impurities	Hand Sanitizer sampling & testing	Passed Test
Hand Sanitizer (ISOPROPANOL ALCOHOL)	Strikingly Fresh Instant Hand Sanitizer Spray	LIQUID	Fumari, Inc.	Assay, Impurities	Hand Sanitizer sampling & testing	Passed Test
Hand Sanitizer (ISOPROPANOL ALCOHOL)		LIQUID	NATURAL COSMETIC LABS USA INC	Assay, Impurities	Hand Sanitizer sampling & testing	Passed Test
Hand Sanitizer (ISOPROPANOL ALCOHOL)		LIQUID	Tiodize Co Inc	Assay, Impurities	Hand Sanitizer sampling & testing	Passed Test
Hand Sanitizer (ISOPROPANOL ALCOHOL)		LIQUID	Barley Creek Associates, LP	Assay, Impurities	Hand Sanitizer sampling & testing	Passed Test
Hand Sanitizer (ISOPROPANOL ALCOHOL)		LIQUID	QUEST INDUSTRIAL	Assay, Impurities	Hand Sanitizer sampling & testing	Passed Test
Hand Sanitizer (ISOPROPANOL ALCOHOL)		LIQUID	Benjamin Moore & Co	Assay, Impurities	Hand Sanitizer sampling & testing	Passed Test
Hand Sanitizer (ISOPROPANOL ALCOHOL)		LIQUID	Anchor Seal Inc	Assay, Impurities	Hand Sanitizer sampling & testing	Passed Test
Hand Sanitizer (Ethanol Alcohol)		LIQUID	Southampton Partners LLC	Assay, Impurities	Hand Sanitizer sampling & testing	Passed Test
Hand Sanitizer (Ethanol Alcohol)	SUN WAVE ANTISEPTIC HAND SANITIZER ALCOHOL ANTISEPTIC 70%	GEL (Gel Based Notification Sent By DPA)	SUN WAVE WELLNESS LLC	Microbials	Hand Sanitizer sampling & testing	Passed Test
Hand Sanitizer (Ethanol Alcohol)		LIQUID	The Dow Chemical Company	Assay, Impurities	Hand Sanitizer sampling & testing	Passed Assay; Failed Impurities
Hand Sanitizer (ISOPROPANOL ALCOHOL)	Purity Isopropyl Alcohol Antiseptic 75% Topical Solution Hand Sanitizer Non-sterile	LIQUID	Vision Chemical Systems	Assay, Impurities	Hand Sanitizer sampling & testing	Passed Test
Hand Sanitizer (ISOPROPANOL ALCOHOL)	FLEX Liquid Hand Sanitizer Isopropyl Alcohol Antiseptic 75% Topical Solution	LIQUID	R. R. Street & Co. Inc.	Assay, Impurities	Hand Sanitizer sampling & testing	Passed Test
Hand Sanitizer (ISOPROPANOL ALCOHOL)	Ricca Topical Hand Sanitizer	LIQUID	Ricca Chemical Company, LLC	Assay, Impurities	Hand Sanitizer sampling & testing	Passed Test
Hand Sanitizer (Ethanol Alcohol)	Beaverkill Alcohol Antiseptic 80% topical solution	LIQUID	Prohibition Distillery LLC	Assay, Impurities		Failed Test
Hand Sanitizer (Ethanol Alcohol)	PCI Clean X Hand Sanitizer	LIQUID	Pacifica Chemical Inc	Assay, Impurities	Hand Sanitizer sampling & testing	Passed Assay; Failed Impurities
Hand Sanitizer (Ethanol Alcohol)		LIQUID	New Age Renewable Energy LLC	Assay, Impurities	Hand Sanitizer sampling & testing	Failed Assay and Impurities
Hand Sanitizer (Ethanol Alcohol)	Angel's Envy Distillery Hand Sanitizer	LIQUID	Louisville Distilling Company, LLC	Microbials	Hand Sanitizer sampling & testing	Passed Test
Hand Sanitizer (Ethanol Alcohol)		LIQUID	Multi-Flow Industries LLC	Assay, Impurities	Hand Sanitizer sampling & testing	Passed Assay; Failed Impurities
Hand Sanitizer (ISOPROPANOL ALCOHOL)		LIQUID	The Sherwin Williams Company	Assay, Impurities	Hand Sanitizer sampling & testing	Passed Test
Hand Sanitizer (ISOPROPANOL ALCOHOL)		LIQUID	Aotco Metal Finishing	Assay, Impurities	Hand Sanitizer sampling & testing	Passed Test
MOMETASONE FUROATE Monohydrate	Nasonex	SPRAY, METERED	MSD International GmbH (Singapore Branch)	Microbials, Sterility, pH, Assay, Identification, Impurities, Minimum Fill	Annual surveillance sampling and testing	Passed Test
TACROLIMUS	Generic	CAPSULE	Intas Pharmaceuticals Limited	Assay, Dissolution, Identification, Impurities	Annual surveillance sampling and testing	Passed Test
AMPHETAMINE	Generic	TABLET	Epic Pharma, LLC	Content Uniformity, Dissolution, Enantiomers, Identification, Impurities, Water Determination	Annual surveillance sampling and testing	Passed Test
AMPHETAMINE	Generic	TABLET	SpecGx, LLC	Content Uniformity, Dissolution, Identification, Enantiomer Ratio	Annual surveillance sampling and testing	Passed Test
CIPROFLOXACIN	Generic	TABLET	Carlsbad Technology, Inc	Content Uniformity, Dissolution, Impurities	Annual surveillance sampling and testing	Passed Test
DOXYCYCLINE HYCLATE	Generic	TABLET	Zhejiang Huahai Pharmaceutical Co., Ltd.	Content Uniformity, Dissolution, Impurities, Identification	Import surveillance sampling and testing	Passed Test
DULOXETINE HYDROCHLORIDE	Generic	CAPSULE	Zhejiang Huahai Pharmaceutical Co., Ltd.	Content Uniformity, Dissolution, Identification, Impurities	Import surveillance sampling and testing	Passed Test
BENAZEPRIL HYDROCHLORIDE	Generic	TABLET, COATED	Zhejiang Huahai Pharmaceutical Co., Ltd.	Content Uniformity, Dissolution, Identification, Impurities	Import surveillance sampling and testing	Passed Test
HEPARIN SODIUM	Generic	INJECTION	Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd.	Sterility, Bacterial Endotoxins, pH, Assay, Benzyl Alcohol Content, Impurities	Import surveillance sampling and testing	Passed Test
Acetaminophen		Oral suspension	Melubryna	Identification, pH, Assay, Impurities, Content Uniformity, Limit of diethylene glycol and ethylene glycol in glycerin	For cause investigation	Passed Test
Buprenorphine		API	SpecGx LLC	Assay, Impurities	Opioid Surveillance	Passed Test
Buprenorphine		API	SpecGx LLC	Assay, Impurities	Opioid Surveillance	Passed Test
Buprenorphine		API	Noramco, Inc	Assay, Impurities	Opioid Surveillance	Passed Test
Buprenorphine		API	Johnson Matthey Inc	Assay, Impurities	Opioid Surveillance	Passed Test
Buprenorphine		API	AVEVA Drug Delivery Systems, Inc.	Assay, Impurities	Opioid Surveillance	Passed Test
Buprenorphine HCl		API	Rhodes Technologies	Assay, Impurities	Opioid Surveillance	Passed Test
Buprenorphine HCl		API	Medisca	Assay, Impurities	Opioid Surveillance	Passed Test
Buprenorphine HCl		API	Janssen Pharmaceutical Inc	Assay, Impurities	Opioid Surveillance	Passed Test
Buprenorphine HCl		API	Noramco, Inc	Assay, Impurities	Opioid Surveillance	Passed Test
Buprenorphine HCl		API	Noramco, Inc	Assay, Impurities	Opioid Surveillance	Passed Test
Buprenorphine HCl		API	Medisca, Inc.,		Opioid Surveillance	Passed Test
Fentanyl		API	Johnson Matthey Inc	Assay, Impurities	Opioid Surveillance	Passed Test
Fentanyl Citrate		API	Cedarburg Pharmaceuticals Inc	Assay, Impurities	Opioid Surveillance	Passed Test
Fentanyl Citrate		API	Johnson Matthey Inc	Assay, Impurities	Opioid Surveillance	Passed Test
Fentanyl Citrate		API	Letco Medical Inc	Assay, Impurities	Opioid Surveillance	Passed Test
Hydrocodone Bitartrate		API	Noramco, Inc	Assay, Impurities	Opioid Surveillance	Passed Test
Hydrocodone Bitartrate		API	Letco Medical Inc	Assay, Impurities	Opioid Surveillance	Passed Test
Hydrocodone Bitartrate		API	Noramco, Inc	Assay, Impurities	Opioid Surveillance	Passed Test
Hydromorphone HCl		API	Johnson Matthey Inc	Assay, Impurities	Opioid Surveillance	Passed Test
Hydromorphone HCl		API	Letco Medical Inc	Assay, Impurities	Opioid Surveillance	Passed Test
Hydromorphone HCl		API	Rhodes Technologies	Assay, Impurities	Opioid Surveillance	Passed Test
Morphine Sulfate		API	MALLINCKRODT INC	Assay, Impurities	Opioid Surveillance	Passed Test
Morphine Sulfate		API	Johnson Matthey Inc	Assay, Impurities	Opioid Surveillance	Passed Test
Morphine Sulfate		API	Noramco, Inc	Assay, Impurities	Opioid Surveillance	Passed Test
Morphine Sulfate		API	Noramco, Inc	Assay, Impurities	Opioid Surveillance	Passed Test
Morphine Sulfate		API	Noramco, Inc	Assay, Impurities	Opioid Surveillance	Passed Test
Morphine Sulfate		API	Medisca	Assay, Impurities	Opioid Surveillance	Passed Test
Morphine Sulfate		API	Medisca	Assay, Impurities	Opioid Surveillance	Passed Test
Morphine Sulfate		API	SpecGx LLC	Assay, Impurities	Opioid Surveillance	Passed Test
Morphine Sulfate		API	Johnson Matthey Inc	Assay, Impurities	Opioid Surveillance	Passed Test
Sufentanil Citrate		API	SpecGx LLC	Assay, Impurities	Opioid Surveillance	Passed Test
Sufentanil Citrate		API	Medisca	Assay, Impurities	Opioid Surveillance	Passed Test
Sufentanil Citrate		API	SpecGx LLC	Assay, Impurities	Opioid Surveillance	Passed Test
Sufentanil Citrate		API	SpecGx LLC	Assay, Impurities	Opioid Surveillance	Passed Test
Sufentanil Citrate		API	Medisca	Assay, Impurities	Opioid Surveillance	Passed Test
PREGNENOLONE		API	MEDISCA INC	Elemental Analysis	Compounding Initiative	Passed Test
PREGNENOLONE		API	MEDISCA INC	Elemental Analysis	Compounding Initiative	Passed Test
PREGNENOLONE		API	Fagron, Inc	Elemental Analysis	Compounding Initiative	Passed Test
PREGNENOLONE		API	LETCO MEDICAL INC	Elemental Analysis	Compounding Initiative	Passed Test
PREGNENOLONE		API	LETCO MEDICAL INC	Elemental Analysis	Compounding Initiative	Passed Test
PREGNENOLONE		API	B&B PHARMACEUTICALS, INC.	Elemental Analysis	Compounding Initiative	Passed Test
PREGNENOLONE		API	PROFESSIONAL COMPOUNDING CENTERS OF AMERICA, LLC	Elemental Analysis	Compounding Initiative	Passed Test
PYRIDOXAL 5 PHOSPHATE		API	Fagron, Inc	Elemental Analysis	Compounding Initiative	Passed Test
PYRIDOXAL 5 PHOSPHATE		API	PROFESSIONAL COMPOUNDING CENTERS OF AMERICA, LLC	Elemental Analysis	Compounding Initiative	Passed Test
PYRIDOXAL 5 PHOSPHATE		API	MEDISCA INC	Elemental Analysis	Compounding Initiative	Passed Test
KOJIC ACID POWDER		API	Fagron, Inc	Elemental Analysis	Compounding Initiative	Passed Test
KOJIC ACID POWDER		API	PROFESSIONAL COMPOUNDING CENTERS OF AMERICA, LLC	Elemental Analysis	Compounding Initiative	Passed Test
KOJIC ACID POWDER		API	MEDISCA INC	Elemental Analysis	Compounding Initiative	Passed Test
KOPI JANTAN TRADISIONAL NATURAL HERBS COFFEE		Supplement	KOPI JANTAN	Screening for Undeclared Ingredient	Online Surveillance	Failed Test
Kopi JANTAN TRADISIONAL Natural Herbs Coffee		Supplement	Amazon	Screening for Undeclared Ingredient	Online Surveillance	Failed Test
ROYAL VIP HONEY		Supplement	ROYAL	Screening for Undeclared Ingredient	Online Surveillance	Failed Test
Royal VIP Honey		Supplement	eBay	Screening for Undeclared Ingredient	Online Surveillance	Failed Test
MERO MACHO		Supplement	MERO	Screening for Undeclared Ingredient	Online Surveillance	Failed Test
MAXFUEL		Supplement	MAXFUEL	Screening for Undeclared Ingredient	Online Surveillance	Passed Test
Imperial Platinum 2000		Supplement	Amazon	Screening for Undeclared Ingredient	Online Surveillance	Failed Test
Imperial Gold 2000		Supplement	Amazon	Screening for Undeclared Ingredient	Online Surveillance	Failed Test
Imperial Extreme 2000		Supplement	Amazon	Screening for Undeclared Ingredient	Online Surveillance	Failed Test
Loaded Hot Rod		Supplement	Amazon	Screening for Undeclared Ingredient	Online Surveillance	Failed Test
PremierZen Gold 7000		Supplement	eBay	Screening for Undeclared Ingredient	Online Surveillance	Failed Test
PremierZen Platinum 5000		Supplement	Amazon	Screening for Undeclared Ingredient	Online Surveillance	Failed Test
PremierZen Black 5000		Supplement	Amazon	Screening for Undeclared Ingredient	Online Surveillance	Failed Test
PremierZen Extreme 3000		Supplement	Amazon	Screening for Undeclared Ingredient	Online Surveillance	Failed Test
PremierZen Platinum 8000		Supplement	eBay	Screening for Undeclared Ingredient	Online Surveillance	Failed Test
Poseidon Platinum 3500		Supplement	eBay	Screening for Undeclared Ingredient	Online Surveillance	Failed Test
Poseidon Platinum 10000		Supplement	eBay	Screening for Undeclared Ingredient	Online Surveillance	Failed Test
Shogun-X Platinum 7000		Supplement	Amazon	Screening for Undeclared Ingredient	Online Surveillance	Failed Test
Shotgun-X 15000		Supplement	Amazon	Screening for Undeclared Ingredient	Online Surveillance	Failed Test
Thumbs Up 7 Black 25K		Supplement	Amazon	Screening for Undeclared Ingredient	Online Surveillance	Failed Test
Thumbs Up 7 White 11K		Supplement	Amazon	Screening for Undeclared Ingredient	Online Surveillance	Failed Test
Thumbs Up 7 Blue 69K		Supplement	Amazon	Screening for Undeclared Ingredient	Online Surveillance	Failed Test
Thumbs up 7 Red 70K		Supplement	Amazon	Screening for Undeclared Ingredient	Online Surveillance	Failed Test
New Thumbs up 7 Red 70K		Supplement	Amazon	Screening for Undeclared Ingredient	Online Surveillance	Failed Test
OrgaZen 7000		Supplement	Amazon	Screening for Undeclared Ingredient	Online Surveillance	Failed Test
Ginseng Power 5000		Supplement	Amazon	Screening for Undeclared Ingredient	Online Surveillance	Failed Test
Primavera		Supplement	Amazon	Screening for Undeclared Ingredient	Online Surveillance	Failed Test
White Dragon		Supplement	Amazon	Screening for Undeclared Ingredient	Online Surveillance	Failed Test
Triple SupremeZen Plus 3500		Supplement	Amazon	Screening for Undeclared Ingredient	Online Surveillance	Failed Test
TRIPLE SupremeZen Extreme 3500		Supplement	Amazon	Screening for Undeclared Ingredient	Online Surveillance	Failed Test
Triple SupremeZen Gold 3500		Supplement	Amazon	Screening for Undeclared Ingredient	Online Surveillance	Failed Test
Triple Wicked Platinum		Supplement	eBay	Screening for Undeclared Ingredient	Online Surveillance	Failed Test
Krazy Night		Supplement	Amazon	Screening for Undeclared Ingredient	Online Surveillance	Failed Test
3 KO Gold XT		Supplement	Amazon	Screening for Undeclared Ingredient	Online Surveillance	Failed Test
Rocky Steady 72 HOURS		Supplement	Amazon	Screening for Undeclared Ingredient	Online Surveillance	Failed Test
69 MODE Blue 69		Supplement	Amazon	Screening for Undeclared Ingredient	Online Surveillance	Failed Test
Red Spartan 3000		Supplement	Amazon	Screening for Undeclared Ingredient	Online Surveillance	Failed Test
Mero Macho		Supplement	eBay	Screening for Undeclared Ingredient	Online Surveillance	Failed Test
Black Stallion 9000		Supplement	eBay	Screening for Undeclared Ingredient	Online Surveillance	Failed Test
Supper Panther 77k		Supplement	eBay	Screening for Undeclared Ingredient	Online Surveillance	Failed Test
White Panther		Supplement	eBay	Screening for Undeclared Ingredient	Online Surveillance	Failed Test
Black Panther Extreme 75K		Supplement	eBay	Screening for Undeclared Ingredient	Online Surveillance	Failed Test
MaxFuel		Supplement	eBay	Screening for Undeclared Ingredient	Online Surveillance	Passed Test
maXXzen Platinum 1200 PREMIER		Supplement	eBay	Screening for Undeclared Ingredient	Online Surveillance	Failed Test
Gold Lion		Supplement	eBay	Screening for Undeclared Ingredient	Online Surveillance	Failed Test
Losartan potassium		Tablet	Merck Sharp & Dohme Corp.	Potency, Dissolution	Consumer Complaint	Passed Test
Intimate Disinfection Spray		Homeopathic	Kadesh	Metals Analysis	Surveillance	Passed Test
Puriton Skin Protectant		Homeopathic	Kadesh	Metals Analysis	Surveillance	Passed Test
Puriton Facial Skin Protectant and Acne Treatment		Homeopathic	Kadesh	Metals Analysis	Surveillance	Passed Test
Puriton First Aid Antiseptic and Antibiotic		Homeopathic	Kadesh	Metals Analysis	Surveillance	Passed Test
Enoxaparin Sodium Injection, 30 mg/0.3 mL		Injectable	Meitheal Pharmaceuticals Inc.	Impurities	Import surveillance sampling and testing	Passed Test
Enoxaparin Sodium Injection, 60 mg/0.6 mL		Injectable	Meitheal Pharmaceuticals Inc.	Impurities	Import surveillance sampling and testing	Passed Test
Enoxaparin Sodium Injection, 80 mg/0.8 mL		Injectable	Meitheal Pharmaceuticals Inc.	Impurities	Import surveillance sampling and testing	Passed Test
Enoxaparin Sodium Injection, 80 mg/0.8 mL		Injectable	Northstar Rx LLC	Impurities	Import surveillance sampling and testing	Passed Test
Enoxaparin Sodium Injection, 60 mg/0.6 mL		Injectable	Northstar Rx LLC	Impurities	Import surveillance sampling and testing	Passed Test
Enoxaparin Sodium Injection, 30 mg/0.3 mL		Injectable	Northstar Rx LLC	Impurities	Import surveillance sampling and testing	Passed Test
ENOXAPARIN SODIUM	Generic	INJECTION	Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd.	Potency, Impurities, Sterility, Bacterial Endotoxins	Import surveillance sampling and testing	Passed Test
Enoxaparin Sodium Injection, 30 mg/0.3 mL		Injectable	Meitheal Pharmaceuticals Inc.	Potency	Import surveillance sampling and testing	Passed Test
Enoxaparin Sodium Injection, 60 mg/0.6 mL		Injectable	Meitheal Pharmaceuticals Inc.	Potency	Import surveillance sampling and testing	Passed Test
Enoxaparin Sodium Injection, 80 mg/0.8 mL		Injectable	Meitheal Pharmaceuticals Inc.	Potency	Import surveillance sampling and testing	Passed Test
Enoxaparin Sodium Injection, 80 mg/0.8 mL		Injectable	Northstar Rx LLC	Potency	Import surveillance sampling and testing	Passed Test
Enoxaparin Sodium Injection, 60 mg/0.6 mL		Injectable	Northstar Rx LLC	Potency	Import surveillance sampling and testing	Passed Test
Enoxaparin Sodium Injection, 30 mg/0.3 mL		Injectable	Northstar Rx LLC	Potency	Import surveillance sampling and testing	Passed Test
Enoxaparin Sodium Injection, 40 mg/0.4 mL		Injectable	Meitheal Pharmaceuticals Inc.	Potency	Import surveillance sampling and testing	Passed Test
Enoxaparin Sodium Injection, 40 mg/0.4 mL		Injectable	Meitheal Pharmaceuticals Inc.	Potency	Import surveillance sampling and testing	Passed Test
Enoxaparin Sodium Injection, 30 mg/0.3 mL		Injectable	Meitheal Pharmaceuticals Inc.	Potency	Import surveillance sampling and testing	Passed Test
Enoxaparin Sodium Injection, 150 mg/mL		Injectable	Meitheal Pharmaceuticals Inc.	Potency	Import surveillance sampling and testing	Passed Test
Enoxaparin Sodium Injection, 40 mg/0.4 mL		Injectable	Meitheal Pharmaceuticals Inc.	Potency	Import surveillance sampling and testing	Passed Test
Enoxaparin Sodium Injection, 100 mg/mL		Injectable	Northstar Rx LLC	Potency	Import surveillance sampling and testing	Passed Test
Enoxaparin Sodium Injection, 100 mg/mL		Injectable	Northstar Rx LLC	Potency	Import surveillance sampling and testing	Passed Test
Enoxaparin Sodium Injection, 60 mg/0.6 mL		Injectable	Northstar Rx LLC	Potency	Import surveillance sampling and testing	Passed Test
Enoxaparin Sodium Injection, 100 mg/mL		Injectable	Northstar Rx LLC	Potency	Import surveillance sampling and testing	Passed Test
Enoxaparin Sodium Injection, 80 mg/0.8 mL		Injectable	Northstar Rx LLC	Potency	Import surveillance sampling and testing	Passed Test
Enoxaparin Sodium Injection, 150 mg/mL		Injectable	Northstar Rx LLC	Potency	Import surveillance sampling and testing	Passed Test
Enoxaparin Sodium Injection, 150 mg/mL		Injectable	Northstar Rx LLC	Potency	Import surveillance sampling and testing	Passed Test
Phenazopyridine HCl, 100 mg		Tablet	Winder Laboratories	Assay, Content Uniformity, Dissolution	For cause investigation	Passed Test
Phenazopyridine HCl, 200 mg		Tablet	Winder Laboratories	Assay, Content Uniformity, Dissolution	For cause investigation	Passed Test
Phenazopyridine HCl, 100 mg		Tablet	Viviet	Assay, Content Uniformity, Dissolution	For cause investigation	Passed Test
Buprenorphine		API	Cambrex Charles City Inc	Assay, Impurities	Opioid Surveillance	Passed Test
Buprenorphine HCl		API	SpecGx LLC	Assay, Impurities	Opioid Surveillance	Passed Test
Fentanyl Base		API	Cambrex Charles City Inc	Assay, Impurities	Opioid Surveillance	Passed Test
Fentanyl Citrate		API	Medisca	Assay, Impurities	Opioid Surveillance	Passed Test
Fentanyl Citrate		API	SpecGx LLC	Assay, Impurities	Opioid Surveillance	Passed Test
Fentanyl Citrate		API	Cambrex Charles City Inc	Assay, Impurities	Opioid Surveillance	Passed Test
Fentanyl Citrate		API	Medisca	Assay, Impurities	Opioid Surveillance	Passed Test
Fentanyl Citrate		API	SpecGx LLC	Assay, Impurities	Opioid Surveillance	Passed Test
Hydrocodone Bitartrate		API	Rhodes Technologies	Assay, Impurities	Opioid Surveillance	Passed Test
Hydrocodone Bitartrate		API	SpecGx LLC	Assay, Impurities	Opioid Surveillance	Passed Test
Hydrocodone Bitartrate		API	Noramco, Inc	Assay, Impurities	Opioid Surveillance	Passed Test
Hydrocodone Bitartrate		API	Noramco, Inc	Assay, Impurities	Opioid Surveillance	Passed Test
Hydrocodone Bitartrate		API	Cambrex Charles City Inc	Assay, Impurities	Opioid Surveillance	Passed Test
Hydrocodone Bitartrate		API	SpecGx LLC	Assay, Impurities	Opioid Surveillance	Passed Test
Hydromorphone HCl		API	Medisca	Assay, Impurities	Opioid Surveillance	Passed Test
Hydromorphone HCl		API	SpecGx LLC	Assay, Impurities	Opioid Surveillance	Passed Test
Hydromorphone HCl		API	SpecGx LLC	Assay, Impurities	Opioid Surveillance	Passed Test
Hydromorphone HCl		API	Medisca	Assay, Impurities	Opioid Surveillance	Passed Test
Hydromorphone HCl		API	Medisca	Assay, Impurities	Opioid Surveillance	Passed Test
Hydromorphone HCl		API	SpecGx LLC	Assay, Impurities	Opioid Surveillance	Passed Test
Nalbuphine HCl		API	MALLINCKRODT INC	Assay, Impurities	Opioid Surveillance	Passed Test
Nalbuphine HCl		API	SpecGx LLC	Assay, Impurities	Opioid Surveillance	Passed Test
Sufentanil Citrate		API	SpecGx LLC	Assay, Impurities	Opioid Surveillance	Passed Test
Tramadol HCl		API	Supriya Lifescience Limited	Assay, Impurities	Opioid Surveillance	Passed Test
Tramadol HCl		API	Supriya Lifescience Limited	Assay, Impurities	Opioid Surveillance	Passed Test
Tramadol HCl		API	Medisca	Assay, Impurities	Opioid Surveillance	Passed Test
Atazanavir Sulfate 200mg		Capsule	Aurobindo Pharma LTD	Content Uniformity, Impurities	Consumer Complaint	Passed Test
Phenobarbital		Tablet	Winder Laboratories	Assay, Content Uniformity, Dissolution	For Cause investigation	Passed Test
Fruta Planta		Supplement	Amazon/Ebay	Screening for undeclared APIs	Surveillance	Failed Test
Super Slim		Supplement	Amazon/Ebay	Screening for undeclared APIs	Surveillance	Failed Test
Detoxi Slim		Supplement	Amazon/Ebay	Screening for undeclared APIs	Surveillance	Passed Test
AB Slim		Supplement	Amazon/Ebay	Screening for undeclared APIs	Surveillance	Passed Test
Baschi Quick Slimming		Supplement	Amazon/Ebay	Screening for undeclared APIs	Surveillance	Passed Test
Lishou Slimming Coffee		Supplement	Amazon/Ebay	Screening for undeclared APIs	Surveillance	Failed Test
SlimBio Capsules		Supplement	Amazon/Ebay	Screening for undeclared APIs	Surveillance	Passed Test
Fruta Bio		Supplement	Amazon/Ebay	Screening for undeclared APIs	Surveillance	Failed Test
Burn 7		Supplement	Amazon/Ebay	Screening for undeclared APIs	Surveillance	Failed Test
Vitaccino Coffee		Supplement	Amazon/Ebay	Screening for undeclared APIs	Surveillance	Failed Test
Lida Daidaihua Plus		Supplement	Amazon/Ebay	Screening for undeclared APIs	Surveillance	Failed Test
IMPERIAL GOLD 2000		Supplement	Amazon/Ebay	Screening for undeclared APIs	Online Surveillance	Failed Test
PREMIERZEN PLATINUM 5000		Supplement	Amazon/Ebay	Screening for undeclared APIs	Online Surveillance	Failed Test
PREMIERZEN BLACK 5000		Supplement	Amazon/Ebay	Screening for undeclared APIs	Online Surveillance	Failed Test
PREMIERZEN GOLD 7000		Supplement	Amazon/Ebay	Screening for undeclared APIs	Online Surveillance	Failed Test
PremierZen Platinum 8000		Supplement	Amazon/Ebay	Screening for undeclared APIs	Online Surveillance	Failed Test
PREMIERZEN EXTREME 3000		Supplement	Amazon/Ebay	Screening for undeclared APIs	Online Surveillance	Failed Test
THUMBS UP 7 WHITE 11K		Supplement	Amazon/Ebay	Screening for undeclared APIs	Online Surveillance	Failed Test
THUMBS UP 7 BLACK 25K		Supplement	Amazon/Ebay	Screening for undeclared APIs	Online Surveillance	Failed Test
THUMBS UP 7 BLUE 69K		Supplement	Amazon/Ebay	Screening for undeclared APIs	Online Surveillance	Failed Test
THUMBS UP 7 RED 70K		Supplement	Amazon/Ebay	Screening for undeclared APIs	Online Surveillance	Failed Test
THUMBS UP 7 RED 70K		Supplement	Amazon/Ebay	Screening for undeclared APIs	Online Surveillance	Failed Test
GINSENG POWER 5000		Supplement	Amazon/Ebay	Screening for undeclared APIs	Online Surveillance	Failed Test
SHOTGUN-X 15000		Supplement	Amazon/Ebay	Screening for undeclared APIs	Online Surveillance	Failed Test
SHOGUN-X PLATINUM 7000		Supplement	Amazon/Ebay	Screening for undeclared APIs	Online Surveillance	Failed Test
Triple Wicked Platinum		Supplement	Amazon/Ebay	Screening for undeclared APIs	Online Surveillance	Failed Test
Super Panther 77k		Supplement	Amazon/Ebay	Screening for undeclared APIs	Online Surveillance	Failed Test
Black Panther Extreme 75K		Supplement	Amazon/Ebay	Screening for undeclared APIs	Online Surveillance	Failed Test
White Panther		Supplement	Amazon/Ebay	Screening for undeclared APIs	Online Surveillance	Failed Test
Poseidon Platinum 10000		Supplement	Amazon/Ebay	Screening for undeclared APIs	Online Surveillance	Failed Test
POSEIDON PLATINUM 3500		Supplement	Amazon/Ebay	Screening for undeclared APIs	Online Surveillance	Failed Test
LOADED HOT ROD		Supplement	Amazon/Ebay	Screening for undeclared APIs	Online Surveillance	Failed Test
IMPERIAL EXTREME 2000		Supplement	Amazon/Ebay	Screening for undeclared APIs	Online Surveillance	Failed Test
IMPERIAL PLATINUM 2000		Supplement	Amazon/Ebay	Screening for undeclared APIs	Online Surveillance	Failed Test
PRIMAVERA		Supplement	Amazon/Ebay	Screening for undeclared APIs	Online Surveillance	Failed Test
ORGAZEN 7000		Supplement	Amazon/Ebay	Screening for undeclared APIs	Online Surveillance	Failed Test
WHITE DRAGON		Supplement	Amazon/Ebay	Screening for undeclared APIs	Online Surveillance	Failed Test
TRIPLE SUPREMEZEN PLUS 3500		Supplement	Amazon/Ebay	Screening for undeclared APIs	Online Surveillance	Failed Test
TRIPLE SUPREMEZEN EXTREME 3500		Supplement	Amazon/Ebay	Screening for undeclared APIs	Online Surveillance	Failed Test
TRIPLE SUPREMEZEN GOLD 3500		Supplement	Amazon/Ebay	Screening for undeclared APIs	Online Surveillance	Failed Test
KRAZY NIGHT		Supplement	Amazon/Ebay	Screening for undeclared APIs	Online Surveillance	Failed Test
3 KO GOLD XT		Supplement	Amazon/Ebay	Screening for undeclared APIs	Online Surveillance	Failed Test
ROCKY STEADY 72 HOURS		Supplement	Amazon/Ebay	Screening for undeclared APIs	Online Surveillance	Failed Test
69 MODE BLUE 69		Supplement	Amazon/Ebay	Screening for undeclared APIs	Online Surveillance	Failed Test
RED SPARTAN		Supplement	Amazon/Ebay	Screening for undeclared APIs	Online Surveillance	Failed Test
BLACK STALLION 9000		Supplement	Amazon/Ebay	Screening for undeclared APIs	Online Surveillance	Failed Test
MAXXZEN PLATINUM 1200 PREMIER		Supplement	Amazon/Ebay	Screening for undeclared APIs	Online Surveillance	Failed Test
GOLD LION		Supplement	Amazon/Ebay	Screening for undeclared APIs	Online Surveillance	Failed Test
Chloroquine phosphate		Tablets	Bayer	Heavy Metal Contaminants	Covid surveillance	Passed Test
Chloroquine phosphate		Tablets	Bayer	Identification, Assay, Impurities, Dissolution, Residual Solvents	Covid surveillance	Passed Test
Resochin (chloroquine phosphate)		Tablet	Bayer	Identification, Assay, Impurities, Dissolution, Residual Solvents	Quality assessment of covid treatment	Passed Test
Hydroxychloroquine sulfate		Drug Substance	Sci Pharmtech Inc	Assay, Impurities, Residual Solvents, Elemental Impurities	Quality assessment of covid treatment	Passed Test
GUNA-Lite		Injectable	GUNA S.p.A	Alkaloids	Surveillance	Passed Test
Berberis Vulgaris root bark, 50 mL		Extract	GUNA S.p.A	Alkaloids	Surveillance	Failed Test
Arnica Montana, 50 mL		Extract	GUNA S.p.A	Alkaloids	Surveillance	Passed Test
Belladonna, 50 mL		Extract	GUNA S.p.A	Alkaloids	Surveillance	Failed Test
Belladonna, 50 mL		Extract	GUNA S.p.A	Alkaloids	Surveillance	Passed Test
Nux Vomica, 50 mL		Extract	GUNA S.p.A	Alkaloids	Surveillance	Failed Test
Propofol		Injectable	Diprivan	Assay, Impurities	Quality assessment of covid treatment	Passed Test
Phenohytro		Tablets	Winder Laboratories	Assay, Content Uniformity	For cause investigation	Passed Test
Hydrocodone Bitartrate / Acetaminophen		Tablet	Novel Laboratories, Inc	Assay, Adulterants	Opioid Surveillance	Passed Test
Hydrocodone Bitartrate / Acetaminophen		Tablet	Amneal Pharmaceuticals of New York	Assay, Adulterants	Opioid Surveillance	Passed Test
Hydrocodone Bitartrate / Acetaminophen		Tablet	Ohm Laboratories Inc	Assay, Adulterants	Opioid Surveillance	Passed Test
Hydrocodone Bitartrate / Acetaminophen		Tablet	Halo Pharmaceutical, Inc	Assay, Adulterants	Opioid Surveillance	Passed Test
Hydrocodone Bitartrate / Acetaminophen		Tablet	Aurolife Pharma, LLC	Assay, Adulterants	Opioid Surveillance	Passed Test
Hydrocodone Bitartrate / Acetaminophen		Tablet	Actavis Laboratories FL, Inc	Assay, Adulterants	Opioid Surveillance	Passed Test
Hydrocodone Bitartrate / Acetaminophen		Tablet	Tris Pharma Inc	Assay, Adulterants	Opioid Surveillance	Passed Test
Hydrocodone Bitartrate / Acetaminophen		Tablet	Tris Pharma Inc	Assay, Adulterants	Opioid Surveillance	Passed Test
Hydrocodone Bitartrate / Acetaminophen		Tablet	Aurolife Pharma, LLC	Assay, Adulterants	Opioid Surveillance	Passed Test
Hydrocodone Bitartrate / Acetaminophen		Tablet	SpecGx, LLC,	Assay, Adulterants	Opioid Surveillance	Passed Test
Hydrocodone Bitartrate / Acetaminophen		Tablet	SpecGx, LLC,	Assay, Adulterants	Opioid Surveillance	Passed Test
Hydrocodone Bitartrate / Acetaminophen		Tablet	Generics Bidco II LLC d/b/a Prinston Laboratories	Assay, Adulterants	Opioid Surveillance	Passed Test
Hydrocodone Bitartrate / Acetaminophen		Tablet	Generics Bidco II LLC d/b/a Prinston Laboratories	Assay, Adulterants	Opioid Surveillance	Passed Test
Hydrocodone Bitartrate / Acetaminophen		Tablet	Generics Bidco II LLC d/b/a Prinston Laboratories	Assay, Adulterants	Opioid Surveillance	Passed Test
Naltrexone HCl		Tablet	Elite Laboratories Inc	Assay, Adulterants	Opioid Surveillance	Passed Test
Naltrexone HCl		Tablet	Elite Laboratories Inc	Assay, Adulterants	Opioid Surveillance	Passed Test
Naltrexone HCl		Tablet	Elite Laboratories Inc	Assay, Adulterants	Opioid Surveillance	Passed Test
Oxycodone HCl		Tablet	Epic Pharma, LLC	Assay, Adulterants	Opioid Surveillance	Passed Test
Oxycodone HCl		Tablet	Purdue Pharmaceuticals Lp	Assay, Adulterants	Opioid Surveillance	Passed Test
Oxycodone HCl		Tablet	Purdue Pharmaceuticals Lp	Assay, Adulterants	Opioid Surveillance	Passed Test
Oxycodone HCl		Tablet	Purdue Pharmaceuticals Lp	Assay, Adulterants	Opioid Surveillance	Passed Test
Oxycodone HCl		Tablet	Ohm Laboratories Inc	Assay, Adulterants	Opioid Surveillance	Passed Test
Oxycodone HCl		Tablet	Amneal Pharmaceuticals, Inc	Assay, Adulterants	Opioid Surveillance	Passed Test
Oxycodone HCl		Tablet	SpecGx, LLC,	Assay, Adulterants	Opioid Surveillance	Passed Test
Oxycodone HCl		Tablet	Aurolife Pharma, LLC	Assay, Adulterants	Opioid Surveillance	Passed Test
Oxycodone HCl		Tablet	Aurolife Pharma, LLC	Assay, Adulterants	Opioid Surveillance	Passed Test
Oxycodone HCl		Tablet	Mikart LLC	Assay, Adulterants	Opioid Surveillance	Passed Test
Oxycodone HCl		Tablet	Ascent Pharmaceuticals, Inc.,	Assay, Adulterants	Opioid Surveillance	Passed Test
Oxycodone HCl / Acetaminophen		Tablet	SpecGx, LLC,	Assay, Adulterants	Opioid Surveillance	Passed Test
Oxycodone HCl / Acetaminophen		Tablet	SpecGx, LLC,	Assay, Adulterants	Opioid Surveillance	Passed Test
Oxycodone HCl / Acetaminophen		Tablet	Ascent Pharmaceuticals, Inc.,	Assay, Adulterants	Opioid Surveillance	Passed Test
Oxycodone HCl / Acetaminophen		Tablet	Ascent Pharmaceuticals, Inc.,	Assay, Adulterants	Opioid Surveillance	Passed Test
Oxycodone / Acetaminophen		Tablet	Purdue Pharmaceuticals Lp	Assay, Adulterants	Opioid Surveillance	Passed Test
Oxycodone / Acetaminophen		Tablet	Purdue Pharmaceuticals Lp	Assay, Adulterants	Opioid Surveillance	Passed Test
Oxycodone / Acetaminophen		Tablet	Amneal Pharmaceuticals, Inc	Assay, Adulterants	Opioid Surveillance	Passed Test
Oxycodone / Acetaminophen		Tablet	Amneal Pharmaceuticals, Inc	Assay, Adulterants	Opioid Surveillance	Passed Test
Oxycodone / Acetaminophen		Tablet	Par Pharmaceutical	Assay, Adulterants	Opioid Surveillance	Passed Test
Oxycodone / Acetaminophen		Tablet	Aurolife Pharma, LLC	Assay, Adulterants	Opioid Surveillance	Passed Test
Oxycodone / Acetaminophen		Tablet	Aurolife Pharma, LLC	Assay, Adulterants	Opioid Surveillance	Passed Test

FY 19 Results

Drug Name	Trade Name	Dosage Form	Firm	Tests Performed	Why Tested	Result
EVETRIACETAM	Generic	Tablet, Film Coated	Apotex Inc.	Assay, Impurities, Identification	Annual Surveillance Sampling & Testing	Passed Test
LEVETRIACETAM	Keppra XR	Tablet, Film Coated	UCB Pharma S.A.	Assay, Identification, Impurities	Annual Surveillance Sampling & Testing	Passed Test
LEVETRIACETAM	Generic	Tablet, Film Coated	Hetero Labs, Ltd. - Unit III	Assay, Dissolution, Impurities	Annual surveillance sampling and testing	Passed Test
LEVETRIACETAM	Generic	Tablet, Film Coated	Unither Manufacturing LLC.	Assay, Identification, Impurities	Annual surveillance sampling and testing	Passed Test
CLONIDINE HYDROCHLORIDE	Generic	Tablet	Xiamen LP Pharmaceutical Co., Ltd.	Assay, Identification, Impurities	Annual surveillance sampling and testing	Passed Test
NIACIN	Generic	Tablet	Sun Pharmaceutical Industries Limited	Assay, Dissolution	Annual surveillance sampling and testing	Passed Test
AMLODIPINE BESYLATE	Generic	Tablet	Epic Pharma, LLC	Content Uniformity, Dissolution, Impurities, Identification, Physical Attributes	Annual surveillance sampling and testing	Passed Test
SODIUM POLYSTYRENE SULFONATE	Generic	SUSPENSION	CMP Pharma Inc	Elemental Impurities	Annual surveillance sampling and testing	Failed Test
CARBAMAZEPINE	Generic	Tablet, Chewable	Torrent Pharmaceuticals Limited	Assay, Content Uniformity, Dissolution, Elemental Impurities, Identification	Annual surveillance sampling and testing	Passed Test
CARBAMAZEPINE	Generic	SUSPENSION	Morton Grove Pharmaceuticals, Inc.	Elemental Impurities	Annual surveillance sampling and testing	Passed Test
GANCICLOVIR	Generic	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	Gland Pharma Limited	Assay, Sterility, Bacterial Endotoxins, Impurities, Water Determination	Annual surveillance sampling and testing	Passed Test
GANCICLOVIR SODIUM	Generic	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	Fresenius Kabi USA, LLC	Assay, Sterility, Bacterial Endotoxins, Water Determination, Impurities	Annual surveillance sampling and testing	Passed Test
GANCICLOVIR	Generic	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	Fresenius Kabi USA, LLC	Assay, Sterility, Bacterial Endotoxins, Water Determination, Impurities	Annual surveillance sampling and testing	Passed Test
ALBUTEROL SULFATE	Generic	Inhalant	Nephron Sterile Compounding Center, LLC	Sterility, Elemental Impurities, Impurities, Leachables	Annual surveillance sampling and testing	Passed Test
ALBUTEROL SULFATE		Inhalant	The Ritedose Corporation	Elemental Impurities	Annual surveillance sampling and testing	Passed Test
ALBUTEROL SULFATE	Generic	Syrup	Hi-Tech Pharmacal Co. Inc., An AKORN Company	Elemental Impurities	Annual surveillance sampling and testing	Passed Test
PREDNISOLONE SODIUM PHOSPHATE	Prednisolone Sodium Phosphate	Solution	Mikart LLC	Elemental Impurities	Annual surveillance sampling and testing	Passed Test
PREDNISOLONE SODIUM PHOSPHATE	Generic	Solution	Hi-Tech Pharmacal Co. Inc., An AKORN Company	Elemental Impurities	Annual surveillance sampling and testing	Passed Test
PREDNISOLONE SODIUM PHOSPHATE	Generic	Solution	Morton Grove Pharmaceuticals, Inc.	Elemental Impurities	Annual surveillance sampling and testing	Passed Test
NYSTATIN	Generic	SUSPENSION, Elemental Impurities	Pharmaceutical Associates Inc	Elemental Impurities	Annual surveillance sampling and testing	Passed Test
NYSTATIN	Generic	SUSPENSION, Elemental Impurities	Morton Grove Pharmaceuticals	Elemental Impurities	Annual surveillance sampling and testing	Passed Test
ETHACRYNIC ACID	Generic	TABLET	West-Ward Columbus Inc	Content Unifomity, Dissolution, Identification	Annual surveillance sampling and testing	Passed Test
ETHACRYNIC ACID	Generic	TABLET	HIKMA PHARMACEUTICALS USA INC	Content Unifomity, Dissolution	Annual surveillance sampling and testing	Passed Test
NITROFURANTOIN	Generic	SUSPENSION	Novel Laboratories, Inc.	Elemental Impurities	Annual surveillance sampling and testing	Failed Test
NITROFURANTOIN	Generic	SUSPENSION	Nostrum Laboratories, Inc.	Elemental Impurities	Annual surveillance sampling and testing	Passed Test
ZOLPIDEM TARTRATE	Generic	Tablet, Film Coated	Sun Pharmaceutical Industries Limited	Dissolution	Annual surveillance sampling and testing	Passed Test
GALANTAMINE HYDROBROMIDE	Generic	Capsule	Sun Pharmaceutical Industries Limited	Content Uniformity, Dissolution, Impurities, Identification, Physical Attributes	Annual surveillance sampling and testing	Passed Test
METFORMIN HYDROCHLORIDE	Generic	Tablet, Film Coated	Sun Pharmaceutical Industries Limited	Dissolution	Annual surveillance sampling and testing	Passed Test
AMLODIPINE	Generic	TABLET	Lupin Ltd.	Dissolution, Friability, Hardness, Identification, Impurities, Weight Variation	Annual surveillance sampling and testing	Passed Test
NAPROXEN	Generic	SUSPENSION	PALMETTO PHARMACEUTICALS INC	Elemental Impurities	Annual surveillance sampling and testing	Failed Test
Teething Colic Samples		Liquid	Newton Homeopathics	Lead	For Cause Investigation	Passed Test
Teething Colic Samples		Liquid	Four Winds Nutrition	Lead	For Cause Investigation	Passed Test
Teething Colic Samples		Liquid	Webnat	Lead	For Cause Investigation	Passed Test
Teething Colic Samples		Liquid	Megavits	Lead	For Cause Investigation	Passed Test
Teething Colic Samples		Pellets	Megavits	Lead	For Cause Investigation	Passed Test
Teething Colic Samples		Pellets	Newton Homeopathics	Lead	For Cause Investigation	Passed Test
Teething Colic Samples		Pellets	H&M Herbs	Lead	For Cause Investigation	Passed Test
Isotretinoin		Capsule	Douglas Pharmaceuticals	Identification, Strength, Purity	Internet purchased prescription drug imported into US and collected at Courier hub	Passed Test
GUNA-Lite		Injectable	GUNA S.p.A.	Metal Analysis	Surveillance drug import testing	Passed Test
Berberis vulbaris root bark		Injectable	GUNA S.p.A.	Metal Analysis	Surveillance drug import testing	Passed Test
Arnica montana		Injectable	GUNA S.p.A.	Metal Analysis	Surveillance drug import testing	Passed Test
Belladonna		Injectable	GUNA S.p.A.	Metal Analysis	Surveillance drug import testing	Passed Test
Achillea mellefolium		Injectable	GUNA S.p.A.	Metal Analysis	Surveillance drug import testing	Passed Test
Symphytum officinale		Injectable	GUNA S.p.A.	Metal Analysis	Surveillance drug import testing	Passed Test
Sanguinaria canadensis		Injectable	GUNA S.p.A.	Metal Analysis	Surveillance drug import testing	Passed Test
Nux vomica		Injectable	GUNA S.p.A.	Metal Analysis	Surveillance drug import testing	Passed Test
Aconitum nappellus		Injectable	GUNA S.p.A.	Metal Analysis	Surveillance drug import testing	Passed Test
Antimonium tartaricum		Injectable	GUNA S.p.A.	Metal Analysis	Surveillance drug import testing	Failed Test
Baryum oxalsuccinicum		Injectable	GUNA S.p.A.	Metal Analysis	Surveillance drug import testing	Failed Test
povidone-iodine		Liquid	McKesson	Assay, Impurities	Surveillance drug import testing	Passed Test
povidone-iodine		Liquid	Major	Assay, Impurities	Surveillance drug import testing	Passed Test
povidone-iodine		Liquid	Prudue Product L. P.	Assay, Impurities	Surveillance drug import testing	Passed Test
Hyland’s 4 Kids Cold ‘n Mucus oral solution		Liquid	Hyland	Assay, Impurities	Consumer Complaint	Passed Test
Diltiazem hydrochloride extended release capsules		Capsule	Valeant	Dissolution	Surveillance of generic drugs	Passed Test
Diltiazem hydrochloride extended release capsules		Capsule	Valeant	Dissolution	Surveillance of generic drugs	Passed Test
Diltiazem hydrochloride extended release capsules		Capsule	Actavis 600	Dissolution	Surveillance of generic drugs	Passed Test
Diltiazem hydrochloride extended release capsules		Capsule	Actavis 699	Dissolution	Surveillance of generic drugs	Passed Test
Diltiazem hydrochloride extended release capsules		Capsule	Par	Dissolution	Surveillance of generic drugs	Passed Test
Diltiazem hydrochloride extended release capsules		Capsule	SunPharma	Dissolution	Surveillance of generic drugs	Passed Test
Genvoya		Tablet	Gilead Sciences, Inc	Identification, Assay, Degradation Products	Courier Hub prescription drug sampling	Passed Test
Phenobarbital		API	Harman Finochem LTD	Potency, Solubility	For Cause Investigation	Passed Test
Heparin		Injectable	Fresenius Kabi	Identification, Potency	Consumer Complaint	Passed Test
Phenobarbital/Belladonna alkaloids elixir		Elixir	VeV Scientific	Assay	For Cause Investigation	Passed Test
GLUTATHIONE-L-REDUCED		API	Letco Medical INC	Identification, Assay, Elemental Analysis	FDA Compounding Initiative	Passed Test
PYRIDOXAL 5 PHOSPHATE		API	Letco Medical INC	Identification, Assay, Elemental Analysis	FDA Compounding Initiative	Passed Test
KOJIC ACID POWDER		Powder	Letco Medical INC	Identification, Assay, Elemental Analysis	FDA Compounding Initiative	Passed Test
Gelatin Capsule Shells		Capsule	Acg Associated Capsules Pvt. Ltd	Chromium	Surveillance Action Plan	Passed Test
Buprenorphine HCl		API	MACFARLAN SMITH A JOHNSON MATTHEY PLC BUSINESS	Assay, Impurities	Opioid Surveillance Assignment	Passed Test
Buprenorphine HCl		API	Letco Medical Inc	Assay, Impurities	Opioid Surveillance Assignment	Passed Test
Buprenorphine HCl		API	Siegfried USA, LLC	Assay, Impurities	Opioid Surveillance Assignment	Passed Test
Buprenorphine HCl		API	B & B Pharmaceuticals, Inc.	Assay, Impurities	Opioid Surveillance Assignment	Passed Test
Fentanyl Citrate		API	Johnson Matthey Inc	Assay, Impurities	Opioid Surveillance Assignment	Passed Test
Fentanyl Citrate		API	Chattem Chemicals Inc.	Assay, Impurities	Opioid Surveillance Assignment	Passed Test
Fentanyl Citrate		API	B & B Pharmaceuticals, Inc.	Assay, Impurities	Opioid Surveillance Assignment	Passed Test
Hydrocodone Bitartrate		API	B & B Pharmaceuticals, Inc.	Assay, Impurities	Opioid Surveillance Assignment	Passed Test
Hydrocodone Bitartrate		API	Noramco, Inc	Assay, Impurities	Opioid Surveillance Assignment	Passed Test
Hydromorphone HCl		API	Siegfried USA, LLC	Assay, Impurities	Opioid Surveillance Assignment	Passed Test
Hydromorphone HCl		API	Chattem Chemicals Inc.	Assay, Impurities	Opioid Surveillance Assignment	Passed Test
Hydromorphone HCl		API	B & B Pharmaceuticals, Inc.	Assay, Impurities	Opioid Surveillance Assignment	Passed Test
Hydromorphone HCl		API	Noramco, Inc	Assay, Impurities	Opioid Surveillance Assignment	Passed Test
Morphine Sulfate		API	Letco Medical Inc	Assay, Impurities	Opioid Surveillance Assignment	Passed Test
Morphine Sulfate		API	B & B Pharmaceuticals, Inc.	Assay, Impurities	Opioid Surveillance Assignment	Passed Test
Morphine Sulfate		API	Noramco, Inc	Assay, Impurities	Opioid Surveillance Assignment	Passed Test
Nalbuphine HCl		API	Letco Medical Inc	Assay, Impurities	Opioid Surveillance Assignment	Passed Test
Nalbuphine HCl		API	SpecGx LLC	Assay, Impurities	Opioid Surveillance Assignment	Passed Test
Sufentanil Citrate		API	B & B Pharmaceuticals, Inc.	Assay, Impurities	Opioid Surveillance Assignment	Passed Test
Tramadol HCl		API	Medisca Inc.	Assay, Impurities	Opioid Surveillance Assignment	Passed Test
Tramadol HCl		API	Enovachem Pharmaceuticals	Assay, Impurities	Opioid Surveillance Assignment	Passed Test
Tramadol HCl		API	Letco Medical Inc	Assay, Impurities	Opioid Surveillance Assignment	Passed Test
Tramadol HCl		API	B & B Pharmaceuticals, Inc.	Assay, Impurities	Opioid Surveillance Assignment	Passed Test
Monsel’s Solution (Ferric Subsulfate, 20%),		Solution	Gordon Laboratories	Iron and Nitrate Assays	For Cause Investigation	Passed Assay (4 lots); Failed Assay (3 lots)
Polidocanol 2%		Solution	Total Vein Pharmacy	Potency	Surveillance	Failed Test
Valsartan		API	Divi’s	Impurities	Nitrosamine Incident	Failed Test
Dalfampridine extended-release tablets		Tablet	Alkem Laboratories	Dissolution	Consumer Complaint	Passed Test
Rapid-A+ Hand Sanitizer, Alcohol Antiseptic 80% Topical Solution (3 lots)		Liquid	NE Finest LLC	Identification, Assay, Impurities	Surveillance Assignment	Passed Test
Alcohol Antiseptic 80% Topical Solution Non-Sterile (3 lots)		Liquid	Ambrosia Frangrance	Identification, Assay, Impurities	Surveillance Assignment	Passed Test

FY 18 Results

Drug Name	Trade Name	Dosage Form	Firm	Tests Performed	Why Tested	Result
Carboplatin	Generic	Injection	Fresenius Kabi	Sterility, Bacteria Endotoxin, Particulate Matter	Annual surveillance sampling and testing	Passed Test
Clonidine	Generic	Transdermal Patch	Mylan Technologies, Inc.	Assay, Dissolution, Identification, Drug Release, Adhesion	Annual surveillance sampling and testing	Passed Test
Carbamazepine	Generic	Capsule	Nostrum Laboratories Inc.	Assay, Dissolution, Impurities, Identification	Annual surveillance sampling and testing	Passed Test
Apixaban	Eliquis	Tablet	AstraZeneca Pharmaceuticals	Friability, Weight Uniformity, Hardness	Annual surveillance sampling and testing	Passed Test
Prasugrel	Effient	Tablet	Eli Lilly and Company	Friability, Weight Uniformity, Hardness	Annual surveillance sampling and testing	Passed Test
Crude Heparin		Crude heparin on resin beads	Olymel Red Deer	Impurities	Surveillance drug import testing	Passed Test
Crude Heparin		Crude heparin on resin beads	Sanimax IOM	Impurities	Surveillance drug import testing	Passed Test
Crude Heparin		Crude heparin on resin beads	Maple Leaf Foods Inc.	Impurities	Surveillance drug import testing	Passed Test
Crude Heparin		Crude heparin on resin beads	Olymel S.E.C./L.P.	Impurities	Surveillance drug import testing	Passed Test
Crude Heparin		Crude heparin on resin beads	Sanimal Lomex	Impurities	Surveillance drug import testing	Passed Test
Crude Heparin		Crude heparin on resin beads	Sanimax LOM Inc.	Impurities	Surveillance drug import testing	Passed Test
Crude Heparin		Crude heparin on resin beads	Sofina Foods	Impurities	Surveillance drug import testing	Passed Test
Crude Heparin		Crude	Sanimax IOM Inc.	Impurities	Surveillance drug import testing	Passed Test
Crude Heparin		Crude	Nanjing King Biochem Pharm Co.	Impurities	Surveillance drug import testing	Passed Test
Crude Heparin		Crude	Nanjing King-Friend Biochem	Impurities	Surveillance drug import testing	Passed Test
Crude Heparin		Crude	Olymel S.E.C.	Impurities	Surveillance drug import testing	Passed Test
Crude Heparin		Crude	Nanjing King-Friend Biochemical	Impurities	Surveillance drug import testing	Passed Test
Heparin Sodium		API	Bioiberica, S.A.	Impurities	Surveillance drug import testing	Passed Test
Heparin Sodium		API	Jiulong Biopharmaceuticals	Impurities	Surveillance drug import testing	Passed Test
Heparin Sodium		API	Bioiberica	Impurities	Heparin assignment	Passed Test
Heparin Sodium		API	Apl	Impurities	Misbranded product testing	Passed Test
Heparin Sodium		Parenteral	Mylan Laboratories Limited	Impurities	Surveillance drug import testing	Passed Test
Heparin Sodium		Parenteral	Gland Pharma Limited	Impurities	Surveillance drug import testing	Passed Test
Heparin Sodium		Parenteral	Mylan Laboratories Limited	Impurities	Unapproved misbranded drug testing	Passed Test
Heparin Sodium		Parenteral	Fresenius Kabi	Identification, Potency, Impurities	Pharmacy complaint	Passed Test
Heparin Sodium		Sterile Liquid	Fresenius Kabi	Identification, Potency, Impurities	Pharmacy complaint	Passed Test
Heparin Sodium		Delayed Release Tablets	Bioiberica, S.A.	Impurities	Surveillance drug import testing	Passed Test
Heparin Sodium		Parenteral	Mylan Laboratories Ltd.	Impurities	Surveillance drug import testing	Passed Test
Heparin Sodium		Sterile Liquid	Gland Pharma Limited	Impurities	Surveillance drug import testing	Passed Test
Heparin Sodium		Parenteral	Mylan Laboratories Limited, Speciality Formulation Facility	Impurities	Surveillance drug import testing	Passed Test
Heparin Sodium		Sterile Liquid	Aurobindo Pharma Limited, Unit VI	Impurities	Surveillance drug import testing	Passed Test
Heparin Sodium		Parenteral	Mylan Laboratories Limited	Impurities	Handheld testing activities	Passed Test
Hydromorphone HCl		API	Chattem Chemicals Inc	Identification, Assay, Purity, Impurities, Economically motivated adulteration screening	Opioid surveillance assignment	Passed Test
Fentanyl citrate		API	Chattem Chemicals Inc	Identification, Assay, Purity, Impurities, Economically motivated adulteration screening	Opioid surveillance assignment	Passed Test
Tramadol HCl	EnovaRX-Tramadol HCl	API	Enovachem Pharmaceuticals	Assay, Purity, Impurities, Economically motivated adulteration screening	Opioid surveillance assignment	Passed Test
Valsartan	Generic	Tablet	Zhejiang Huahai Pharmacetuicals	Assay, Dissolution	Consumer complaint: side effects related to generic valsartan tablets	Passed Test
Valsartan Hydrochlorothiazide	Generic	Tablet	Aurobindo	Assay, Dissolution	Consumer complaint: side effects related to generic valsartan tablets	Passed Test
Sumatriptan	Imitrex	Tablet	GlaxoSmithKline	Assay, Dissolution	Consumer complaint: side effects related to generic sumatriptan tablets	Passed Test
Sumatriptan	Generic	Tablet	Dr. Reddy	Assay, Dissolution	Consumer complaint: side effects related to generic sumatriptan tablets	Passed Test
Power Patch Skin Patch		Transdermal	AgeForce	Visual evaluation of products	For Cause, firm in violation of cGMP regulations regarding repackaging, relabeling operations and distributions	Failed Test
Feminine Libido Skin Patch		Transdermal	AgeForce	Visual evaluation of products	For Cause, firm in violation of cGMP regulations regarding repackaging, relabeling operations and distributions	Failed Test
DHEA Skin Patch (Female)		Transdermal	AgeForce	Visual evaluation of products	For Cause, firm in violation of cGMP regulations regarding repackaging, relabeling operations and distributions	Failed Test
DHEA Skin Patch (Male)		Transdermal	AgeForce	Visual evaluation of products	For Cause, firm in violation of cGMP regulations regarding repackaging, relabeling operations and distributions	Failed Test
Potassium Chloride		Parenteral	APP Pharma.	Elemental Impurities	Survey of potassium chloride parenteral solutions	Failed Test
Potassium Chloride		Parenteral	B. Braun	Elemental Impurities	Survey of potassium chloride parenteral solutions	Failed Test
Potassium Chloride		Parenteral	Hospira	Elemental Impurities	Survey of potassium chloride parenteral solutions	Passed Test
Acetaminophen	Generic	Tablet	Fortune Pharmacal Co., LTD	Assay, Impurities, Content Uniformity	Survey of acetaminophen OTC products	Passed Test
Acetaminophen	Generic	Gelcaps	Walgreens Co	Assay, Impurities, Content Uniformity	Survey of acetaminophen OTC products	Passed Test
Acetaminophen	Generic	Gelcaps	CVS	Assay, Impurities, Content Uniformity	Survey of acetaminophen OTC products	Passed Test
Acetaminophen	Generic	Liquid	CVS	Assay, Impurities, Content Uniformity	Survey of acetaminophen OTC products	Passed Test
Acetaminophen	Generic	Liquid	Walmart	Assay, Impurities, Content Uniformity	Survey of acetaminophen OTC products	Passed Test
Trandolapril	Generic	Tablet	Lupin	Assay, Dissolution, Content Uniformity	For Cause Investigation	Passed Test
Acetaminophen/Hydrocodone Bitartrate	Generic	Tablet	Amneal	Assay	Consumer complaint	Passed Test
Acetaminophen/Hydrocodone Bitartrate	Generic	Tablet	Qualitest	Assay	Consumer complaint	Passed Test
Acetaminophen/Hydrocodone Bitartrate	Generic	Tablet	Watson	Assay	Consumer complaint	Passed Test
Lisinopril	Generic	Tablet	Lupin	Assay	Consumer complaint	Passed Test
Amlodipine Besylate	Generic	Tablet	Ascend Laboratories	Dissolution, Potency	Consumer complaint	Passed Test
Amlodipine Besylate	Norvasc	Tablet	Pfizer Inc	Dissolution, Potency	Consumer complaint	Passed Test
Atenolol	Generic	Tablet	Zydus	Dissolution, Potency	Consumer complaint	Passed Test
Diltiazem Hydrochloride ER		Capsules	Valeant Internation Bermuda	Dissolution	Surveillance of generic drugs	Passed Test
Diltiazem Hydrochloride ER		Tablet	Valeant Pharmaceutical North America LLC	Dissolution	Surveillance of generic drugs	Passed Test
Diltiazem Hydrochloride ER		Capsules	Valeant Pharmaceutical North America LLC	Dissolution	Surveillance of generic drugs	Passed Test
Diltiazem Hydrochloride ER	Generic	Capsules	Valeant Pharmaceutical North America LLC	Dissolution	Surveillance of generic drugs	Passed Test
Tenoforvir Disoproxil Fumarate		Tablet	CIPLA LTD	Identification, Potency, Purity	Internet purchased prescription drug imported into US and collected at Courier hub	Passed Test
Tenoforvir Disoproxil Fumarate		Tablet	CIPLA LTD	Identification, Potency, Purity	Consumer complaint	Failed Test
Tenoforvir Disoproxil Fumarate	Truvada	Tablet	Gilead Sciences, Inc	Identification, Potency, Purity	Consumer complaint	Passed Test
Levothyroxine Sodium		Tablet	GSK Pharmceutial Ltd	Identification, Potency, Purity	Internet purchased prescription drug imported into US and collected at Courier hub	Passed Test
Diclofenanc Diethylamine	Voltaren	topical	GlaxoSmithKline Inc	Identification, Potency, Purity	Internet purchased prescription drug imported into US and collected at Courier hub	Passed Test
Efavirenz		Tablet	CIPLA LTD	Identification, Potency, Purity	Internet purchased prescription drug imported into US and collected at Courier hub	Passed Test
Diltiazem Hydrochloride ER	Generic	Capsules	Actavis Laboratories FL INC	Dissolution	Surveillance of generic drugs	Passed Test
Diltiazem Hydrochloride ER	Generic	Tablet	Actavis Laboratories FL INC	Dissolution	Surveillance of generic drugs	Passed Test
Diltiazem Hydrochloride ER	Generic	Capsules	Sun Pharma Global FZE	Dissolution	Surveillance of generic drugs	Passed Test
Diltiazem Hydrochloride ER	Generic	Capsules	PAR	Dissolution	Surveillance of generic drugs	Passed Test
Diltiazem Hydrochloride ER	Generic	Capsules	Mylan	Dissolution	Surveillance of generic drugs	Passed Test
Ferric Subsulfate (Monsel's Solution)		Topical	Gordon Laboratories	Iron and Nitrate Assays	For Cause Investigation	Failed Test

FY 17 Results

Drug Name	Trade Name	Dosage Form	Firm	Tests Performed	Why Tested	Result
Amlodipine Besylate	Generic	Tablet	Zydus	Assay, Impurities	Consumer complaint: side effects related to generic amlodipine besylate	Passed Test
Amlodipine Besylate	Norvasc	Tablet	Pfizer	Assay, Impurities	Consumer complaint: side effects related to generic amlodipine besylate	Passed Test
Atracurium Besylate Injection	Atracurium	Injection	Sagent Pharmaceutical	Assay, ID, pH, Sterility, Endotoxin	Annual surveillance sampling and testing	Passed Tests
Atracurium Besylate Injection	Atracurium	Injection	Aurobindo Pharma Limited	Assay, ID, pH, Sterility, Endotoxin	Annual surveillance sampling and testing	Passed Tests
Benazepril HCl	Lotensin	Tablets	Amneal Pharmaceuticals	Assay, Content Uniformity, Dissolution, Impurities, ID	Annual surveillance sampling and testing	Passed Tests
Benazepril HCl	Lotensin	Tablets	Zhejiang Huahai Pharm	Assay, Content Uniformity, Dissolution, Impurities, ID	Annual surveillance sampling and testing	Passed Tests
Benazepril HCl	Lotensin	Tablets	Aurobindo Pharma Ltd	Assay, Content Uniformity, Dissolution, Impurities, ID	Annual surveillance sampling and testing	Passed Tests
Bevacizumab	Avastin	Injection	Genentech	ID, Impurities	Adverse Event: inflammatory response following injection	Passed Test
Carbidopa/Levodopa	Generic	Tablet	Actavis	Dissolution	Comparison of dissolution between RLD and generic Carbidopa/Levodopa IR tablets	Passed Test
Carbidopa/Levodopa	Generic	Tablet	Mylan	Dissolution	Comparison of dissolution between RLD and generic Carbidopa/Levodopa IR tablets	Passed Test
Carbidopa/Levodopa	Generic	Tablet	Sun Pharmaceutical Industries	Dissolution	Comparison of dissolution between RLD and generic Carbidopa/Levodopa IR tablets	Passed Test
Carbidopa/Levodopa	Generic	Tablet	Teva Pharmaceuticals	Dissolution	Comparison of dissolution between RLD and generic Carbidopa/Levodopa IR tablets	Passed Test
Carbidopa/Levodopa	Generic	Tablet	Sun Pharma	Dissolution	Assessment of dissolution of Sun Pharma Cabidopa/Levodopa immediate release tablets	Passed Test
Carbidopa/Levodopa	Sinemet	Tablet	Merck	Dissolution	Comparison of dissolution between RLD and generic Carbidopa/Levodopa IR tablets	Passed Test
Celecoxib	Generic	Capsule	Apotex	Dissolution	Comparison of dissolution between RLD and generic Celecoxib capsule drug products	Passed Test
Celecoxib	Generic	Capsule	Greenstone	Dissolution	Comparison of dissolution between RLD and generic Celecoxib capsule drug products	Passed Test
Celecoxib	Generic	Capsule	Actavis	Dissolution	Comparison of dissolution between RLD and generic Celecoxib capsule drug products	Passed Test
Celecoxib	Generic	Capsule	Mylan	Dissolution	Comparison of dissolution between RLD and generic Celecoxib capsule drug products	Passed Test
Celecoxib	Celebrex	Capsule	Pfizer	Dissolution	Comparison of dissolution between RLD and generic Celecoxib capsule drug products	Passed Test
Divalproex Sodium	Depakote	Tablet	Citron Pharma	ID, assay, content uniformity, dissolution	Consumer complaint: side effects related to generic Divalproex sodium	Passed Test
Divalproex Sodium	Depakote	Tablet	Sun Pharmaceutical Industries	ID, assay, content uniformity, dissolution	Consumer complaint: side effects related to generic Divalproex sodium	Passed Test
Donepezil HCl	Generic	Tablets	Zhejiang Huahai Pharm	Content Uniformity, Dissolution, Impurities, ID	Annual surveillance sampling and testing	Passed Tests
Enalapril Maleate	Generic	Tablet	Wockhardt Ltd.	Unit dose uniformity, dissolution, assay	Complaint: unit dose uniformity	Passed Test
Enalapril Maleate	Vasotec	Tablet	Valeant Pharmaceuticals International, Inc.	Unit dose uniformity, dissolution, assay	Complaint: unit dose uniformity	Passed Test
Heparin	Generic	Injectable	Sanofi	Identity and absence of contaminants	Annual surveillance sampling and testing	Passed Test
Heparin	Generic	Injectable	Gland	Identity and absence of contaminants	Annual surveillance sampling and testing	Passed Test
Heparin	Generic	Injectable	Aurobindo	Identity and absence of contaminants	Annual surveillance sampling and testing	Passed Test
Heparin	Generic	Injectable	Hospira	Identity and absence of contaminants	Annual surveillance sampling and testing	Passed Test
Heparin	Generic	Injectable	Braun	Identity and absence of contaminants	Annual surveillance sampling and testing	Passed Test
Heparin	Generic	Injectable	Fresenius Kabi	Identity and absence of contaminants	Annual surveillance sampling and testing	Passed Test
Irbesartan	Avapro	Tablets	West-Ward Columbus Inc	Dissolution, Impurities, ID	Annual surveillance sampling and testing	Passed Tests
Irbesartan	Avapro	Tablets	Zhejiang Huahai Pharm	Assay, Content Uniformity, Dissolution, Impurities, ID	Annual surveillance sampling and testing	Passed Tests
Lamotrigine	Generic	ER Tablets	Actavis Elizabeth LLC	Impurities, Dissolution, ID, content uniformity	Annual surveillance sampling and testing	Passed Tests
Lamotrigine	Generic	ER Tablets	Zhejiang Huahai Pharm	ID, Content Uniformity, Impurities	Annual surveillance sampling and testing	Passed Tests
Lamotrigine	Generic	Tablets	Dr. Reddy's Laboratories Ltd.	ID, Dissolution, Content Uniformity, Impurities	Annual surveillance sampling and testing	Passed Tests
Levetiracetam	Keppra	ER Tablets	Zhejiang Huahai Pharm	Content Uniformity, Dissolution, Impurities, ID	Annual surveillance sampling and testing	Passed Tests
Levetiracetam	Keppra	Tablets	Mylan Pharm Inc	Content Uniformity, Impurities, ID	Annual surveillance sampling and testing	Passed Tests
Levetiracetam	Keppra	Tablets	Torrent Pharm Ltd	Content Uniformity, Impurities, ID	Annual surveillance sampling and testing	Passed Tests
Losartan Potassium	Generic	Tablets	Jubilant Cadista Pharm Inc	Assay, Content Uniformity, Dissolution, Impurities, ID	Annual surveillance sampling and testing	Passed Tests
Losartan Potassium	Generic	Tablets	Torrent Pharm Ltd	Assay, Content Uniformity, Dissolution, Impurities, ID	Annual surveillance sampling and testing	Passed Tests
Losartan Potassium	Generic	Tablets	Zhejiang Huahai Pharmaceutical Co., Ltd.	Assay, Content Uniformity, Dissolution, Impurities, ID	Annual surveillance sampling and testing	Passed Tests
Nevirapine	Generic	Tablets	Zhejiang Huahai Pharmaceutical Co., Ltd.	Assay, Content Uniformity, Dissolution, Impurities, ID	Annual surveillance sampling and testing	Passed Tests
Nevirapine	Generic	Tablets	Hetero Labs Ltd	Assay, Content Uniformity, Dissolution, Impurities, ID	Annual surveillance sampling and testing	Passed Tests
Omeprazole	Generic	Capsule	Apotex	Assay, Dissolution	Consumer Complaint	Passed Test
Paroxetine	Generic	Tablets	Zhejiang Huahai Pharm	Assay, Content Uniformity, Dissolution, Impurities, ID	Annual surveillance sampling and testing	Passed Tests
Paroxetine	Generic	Tablets	Cadila Healthcare Ltd	Assay, Content Uniformity, Dissolution, Impurities, ID	Annual surveillance sampling and testing	Passed Tests
Ropinirole HCl	rOPINIRole	Tablets	West-Ward Columbus Inc	Content Uniformity, Dissolution, Impurities, ID	Annual surveillance sampling and testing	Passed Tests
Ropinirole HCl	rOPINIRole	Tablets	Zhejiang Huahai Pharm	Content Uniformity, Dissolution, Impurities, ID	Annual surveillance sampling and testing	Passed Tests

FY 16 Results

FY16 Drugs (PDF - 98 KB)

FY16 Active Pharmaceutical Ingredient (PDF - 57.69 KB)

Drug Quality: Postmarket Sampling and Testing Results (FY 2016)

Test results updated bi-annually.

Drug Name	Trade Name	Dosage Form	Firm	Tests Performed	Why Tested	Results
Alprazolam	XANAX (brand)	Tablets	Pfizer Italia	Dissolution, ID, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Alprazolam	XANAX (brand)	Tablets	Pfizer Pharmaceuticals LLC	Dissolution, ID, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Alprazolam	XANAX XR (brand)	Tablets	Pharmacia and Upjohn	Dissolution, ID, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Amoxicillin	Generic	Capsules	American Antibiotics Inc.	Dissolution, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Amoxicillin and Clavulanate Potassium	Generic	Tablets	Dr. Reddy's Laboratories Inc.	Dissolution, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Amoxicillin and Clavulanate Potassium	Generic	Tablets	Lek Pharmaceuticals D.D.	Dissolution, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Amoxicillin and Clavulanate Potassium	Generic	Tablets	Teva Canada Ltd	Dissolution, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Amoxicllin and Clavulanate Potassium	Generic	Tablets	Aurobindo Pharma LTD	Dissolution , CU, WV	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Ciprofloxacin	Generic	Tablets	Dr. Reddy's Laboratories Limited	Dissolution, Raman	Analysis of Drug Release and Potency Using Portable Raman Spectroscopy	Passed Test
Citalopram	Generic	Tablets	Mylan Pharmaceuticals Inc.	Assay, Dissolution, Organic Impurities, CU, WV	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Citalopram Hydrobromide	Generic	Tablets	Epic Pharma, LLC	Dissolution, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Citalopram Hydrobromide	Generic	Tablets	Invagen Pharm	Dissolution, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Citalopram Hydrobromide	CELEXA (brand)	Tablets	H. Lundbeck A/S	Assay, Dissolution, Organic Impurities, ID, CU, WV	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Clindamycin	CLEOCIN (RLD)	Capsules	Pfizer, Inc.	Assay and Impurities	Consumer Complaint: Subpotency	Passed Test
Duloxetine Hydrochloride	CYMBALTA (brand)	Tablets	Lilly del Caribe, Inc.	ID, Assay and Impurities	Foreign Online Pharmacy Surveillance	Passed Test
Erythromycin	Generic	Ophthalmic Ointment	Perrigo	Rheology, particle size, and container uniformity	Quality assessment of commercial ophthalmic ointments	Passed Test
Erythromycin	Generic	Ophthalmic Ointment	Akorn	Rheology, particle size, and container uniformity	Quality assessment of commercial ophthalmic ointments	Passed Test
Erythromycin	Generic	Ophthalmic Ointment	Bausch & Lomb	Rheology, particle size, and container uniformity	Quality assessment of commercial ophthalmic ointments	Passed Test
Ezetimibe and Simvastatin	VYTORIN (brand)	Tablets	MSD International GmbH	Assay, Dissolution, CU, WV	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Gentamicin	GENTAK (brand)	Ophthalmic Ointment	Akorn	Rheology, particle size, and container uniformity	Quality assessment of commercial ophthalmic ointments	Passed Test
Gentamicin Sulfate	Generic	Ophthalmic Ointment	Perrigo	Rheology, particle size, and container uniformity	Quality assessment of commercial ophthalmic ointments	Passed Test
Hydralazine HCl	Generic	Tablets	Glenmark Generics Ltd	Dissolution, ID, Impurities, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Hydralazine HCl	Generic	Tablets	Hetero Drugs Limited	Dissolution, ID, Impurities, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Hydralazine HCl	Generic	Tablets	Heritage Pharmaceuticals Inc.	Dissolution, ID, Impurities, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Metformin HCl	Generic	Extended Release Tablets	Teva Pharm Industries	Dissolution, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Metformin HCl	Generic	Tablets	Blu Caribe Inc	Dissolution, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Metformin HCl	Generic	Tablets	Emcure Pharmaceuticals Limited	Dissolution, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Metformin HCl	Generic	Tablets	Granules Pharmaceuticals	Assay, Dissolution, ID, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Metformin HCl	Generic	Tablets	Sciegen Pharmaceuticals Inc	Dissolution, CU, WV	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Methylphenidate Hydrochloride	CONCERTA (RLD)	Tablets & OETs	Janssen Pharmaceuticals, Inc.	Dissolution	Assess product quality	Passed Test
Methylphenidate Hydrochloride	Generic	Tablets & OETs	Mallinckrodt	Dissolution	Assess product quality	Passed Test
Metoprolol Tartrate	Generic	Tablets	Aurobindo Pharma LTD	Dissolution, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Metoprolol Tartrate	Generic	Tablets	Emcure Pharmaceuticals Limited	Dissolution, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Metoprolol Tartrate	Generic	Tablets	Mylan Pharm	Dissolution, ID, Impurities, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Metoprolol Tartrate	Generic	Tablets	Watson Pharm	Dissolution, ID, Impurities, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Metoprolol Tartrate and Hydrochlorothiazide	Generic	Tablets	Alembic Pharm	Dissolution, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Metoprolol Tartrate and Hydrochlorothiazide	Generic	Tablets	Trigen Labs	Dissolution, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Metronidazole	FLAGYL (brand)	Tablets	Pfizer Inc	Assay, Dissolution, ID, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Metronidazole	Generic	Tablets	Teva Czech Industries	Assay, Dissolution, ID, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Metronidazole	Generic	Tablets	Unichem Laboratories Ltd	Assay, Dissolution, ID, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Midazolam hydrochloride	Generic	Injection	PharMEDium	Assay and Impurities	Assess market quality	Assay Passed, Impurities Failed
Mometasone Furoate Monohydrate	NASONEX (Trade Name)	Nasal Spray	MSD International GmbH	Microbial	Assess pathogens	Passed Test
Neostigmine methylsulfate	Generic	Injection	PharMEDium	Assay and Impurities	Assess stability	Passed Test
Neostigmine methylsulfate	RLD	Injection	Fresenius Kabi	Assay and Impurities	Assess stability	Passed Test
Niacin/Simvastatin	SIMCOR (brand)	Extended Release Tablets	Abbvie Inc	Dissolution, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Norepinephrine Bitartrate	Generic	Injection	PharMEDium	pH Value, Assay and Impurities	Marketplace complaint on color	Failed Test
Oxcarbazepine	Generic	Tablets	Glenmark Generics Ltd	Assay, Dissolution, ID, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Oxcarbazepine	Generic	Tablets	Nexgen Pharma Inc	Assay, Dissolution, ID, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Oxcarbazepine	TRLEPTAL (Brand)	Tablets	Novartis Consumer Healthcare	Assay, Dissolution, ID, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Oxcarbazepine	Generic	Tablets	Sun Pharmaceutical Industries	Dissolution, CU, WV	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Phenytoin Sodium	DILANTIN (RLD)	Capsules	Pfizer Ltd	Assay and Impurities	Foreign Online Pharmacy Surveillance	Passed Test
Phenytoin Sodium	DILANTIN ER (RLD)	Capsule	Pfizer	Dissolution	Performance Comparison of Dissolution Testing between RLD and Generic Phenytoin Sodium ER Drug Product	Passed Test
Phenytoin Sodium USP	Generic	Extended Release Capsule	Sun Pharma	Dissolution	Performance Comparison of Dissolution Testing between RLD and Generic Phenytoin Sodium ER Drug Product	Passed Test
Phenytoin	Generic	Extended Release Capsule	Anmeal Pharmaceuticals LLC	Dissolution	Performance Comparison of Dissolution Testing between RLD and Generic Phenytoin Sodium ER Drug Product	Passed Test
Phenytoin Sodium USP	Generic	Extended Release Capsule	Taro	Dissolution	Performance Comparison of Dissolution Testing between RLD and Generic Phenytoin Sodium ER Drug Product	Passed Test
Pioglitazone HCl and Metformin HCl	Generic	Tablets	Mylan Pharm	Dissolution, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Pravastatin Sodium	Generic	Tablets	Apotex Inc	Dissolution, Impurities, CU, WV	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Pravastatin Sodium	Generic	Tablets	Lupin Limited	Dissolution, ID, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Pravastatin Sodium	Generic	Tablets	Dr. Reddy's Laboratories Ltd	Dissolution, Impurities, CU, WV	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Pravastatin Sodium	Generic	Tablets	Lek Pharmaceuticals Ltd	Dissolution, Impurities, CU, WV	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Pravastatin Sodium	Generic	Tablets	Teva Czech Industries	Dissolution, Impurities, CU, WV	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Pravastatin Sodium	PRAVACHOL (brand)	Tablets	Bristol Myers Squibb Mfg Co.	Assay, Dissolution, CU, WV	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Propafenone HCl	Generic	Tablets	Mutual Pharm Co	Assay, Dissolution, Organic Impurities, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Propafenone HCl	Generic	Tablets	Vintage Pharm (Qualitest Pharm)	Assay, Dissolution, Organic Impurities, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Propranolol HCl	Generic	Extended Release Capsules	Adare Pharmaceuticals	Assay, Dissolution, ID, CU, WV	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Propranolol HCl	Generic	Extended Release Capsules	Aptalis Pharmatech	Assay, Dissolution, ID, CU, WV	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Propranolol HCl	Generic	Tablets	Teva Czech Industries	Assay, Dissolution, ID, CU, WV	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Propranolol HCl	Generic	Tablets	Vintage Pharmaceuticals LLC	Assay, Dissolution, ID, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Simvastatin	Generic	Tablets	Blu Caribe	Content Uniformity	Stability inquiry	Passed Test
Simvastatin	Generic	Tablets	Dr. Reddy's Laboratories Limited	Content Uniformity	Stability inquiry	Passed Test
Simvastatin	Generic	Tablets	Dr. Reddy's Laboratories Limited	Assay, Dissolution, CU, WV	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Simvastatin	Generic	Tablets	Intas Pharmaceuticals Inc	Assay, Dissolution, ID, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Simvastatin	ZOCOR (brand)	Tablets	Merck, Sharpe & Dohme	Assay, Dissolution, CU, WV	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Simvastatin	Generic	Tablets	Teva Czech Industries	Dissolution, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Sulfacetamide sodium	Generic	Ophthalmic Ointment	Perrigo	Rheology, particle size, and container uniformity	Quality assessment of commercial ophthalmic ointments	Passed Test
Tobramycin / Dexamethasone	TOBRADEX (RLD)	Ophthalmic Ointment	Alcon	Rheology, particle size, and container uniformity	Quality assessment of commercial ophthalmic ointments	Passed Test
Venlafaxine HCl	Generic	Extended Release Capsules	Cadila Healthcare	Dissolution, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Venlafaxine HCl	EFFEXOR XR (brand)	Extended Release Capsules	Pfizer Ireland	Dissolution, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Venlafaxine HCl	Generic	Extended Release Capsules	Teva Pharm USA	Dissolution, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Venlafaxine HCl	Generic	Extended Release Capsules	Wockhardt Limited	Dissolution, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Venlafaxine HCl	Generic	Extended Release Tablets	Kremers Urban Pharmaceuticals	Dissolution, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Venlafaxine HCl	Generic	Tablets	Alkaloida Chemical Co Zrt	Dissolution, CU, WV	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Venlafaxine HCl	Generic	Tablets	Mylan Pharmaceuticals	Dissolution, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Venlafaxine HCl	Generic	Tablets	Vintage Pharmaceuticals LLC	Dissolution, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test

FY 15 Results

FY15 Drugs (PDF - 93.24 KB)

FY15 Active Pharmaceutical Ingredient (PDF - 73.20 KB)

Drug Quality: Postmarket Sampling and Testing Results (FY 2015)

Test results updated bi-annually.

Drug Name	Trade Name	Dosage Form	Firm	Tests Performed	Why Tested	Results
Alprazolam	XANAX XR (brand)	Extended Release Tablets	Pfizer Italia S.r.l.	Dissolution, ID, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Alprazolam	XANAX (brand)	Tablets	Pfizer Pharmaceuticals LLC	Dissolution, ID, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Amoxicillin	Generic	Capsules	American Antibiotics Inc.	Dissolution, ID, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Amoxicillin	Generic	Tablets	Teva Canada Ltd	Assay, Dissolution, ID, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Amoxicillin	Generic	Tablet	Sandoz	Assay and Raman Comparison	Consumer complaint (ineffectiveness)	Passed Test
Amphotericin B	Generic	For Injection	X-Gen Pharmaceuticals, Inc.	Assay	Assess potency	Passed Test
Brompheniramine Maleate / Pseudoephedrine Hydrochloride / Dextromethorphan Hydrobromide	BROMFED DM (RLD)	Oral Syrup	Wockhardt	Propylene Glycol content via HPLC-RI	Determine propylene glycol content	Passed Test
Buprenorphine	BUTRANS (RLD)	Transdermal	LTS Lohmann Therapie-Systeme AG	Test separation of inner disk from system	Reports that inner disk could be easily removed from generic product	Passed Test
Buprenorphine	Generic	Transdermal	Actavis Laboratories, Inc.	Test separation of inner disk from system	Reports that inner disk could be easily removed from generic product	Failed Test
Cephalexin	Generic	Capsules	Aurobindo Pharma Limited	Assay, Impurities (HPLC & HPLC-MS), NMR	Adverse event	Passed Test
Colistimethate	Generic	For Injection	JHP Pharmaceuticals	Assay	Assess potency accuracy	Passed Test
Colistimethate	Generic	For Injection	X-Gen Pharmaceuticals	Assay	Assess potency accuracy	Passed Test
Cyclosporine (Restasis® )	RESTASIS (RLD)	Ophthalmic Emulsion	Allergan	Globule size distribution and zeta potential of various lots to determine variability of RLD	Comparative clinical endpoint study	Passed Test
Deoxycholic acid	KYBELLA (RLD)	Injection Solution	Kythera Biopharmaceuticals Inc.	ID, assay and impurities	Assess market quality	Passed Test
Doxorubicin HCl Liposome	DOXIL (RLD)	Injection	Janssen	Total Sulfate, Histidine (LC-MS), and ammonium sulfate (SAX)	Comparative study	Passed Test
Doxorubicin HCl Liposome	Generic	Injection	Sun Pharmaceuticals	Total Sulfate, Histidine (LC-MS), and ammonium sulfate (SAX)	Comparative study	Passed Test
Doxycycline Hyclate	Generic	Capsules	West-Ward Pharmaceuticals	Assay and Impurities Testing (USP)	Assess market quality	Passed Test
Heparin Sodium	Generic	IV Solution	B. Braun Medical Inc.	USP potency (anti-factor IIa) testing, strong anion exchange high performance liquid chromatography (SAX-HPLC), and 1D proton nuclear magnetic resonance (NMR)	Adverse event	Passed Test
Hydralazine HCl	Generic	Tablets	Hetero Drugs Limited	Dissolution, Impurities, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Hydralazine HCl	Generic	Tablets	Teva Czech Industries s.r.o.	Dissolution, Impurities, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Hydrocodone Bitartrate and Acetaminophen	Generic	Tablets	Sun Pharmaceuticals	Dissolution	Consumer complaint: lack of efficacy	Passed Test
Hydrocodone Bitartrate and Acetaminophen	Generic	Tablets	Mallinckrodt, Inc.	Dissolution	Consumer complaint: lack of efficacy	Passed Test
Hydrocodone Bitartrate and Acetaminophen	Generic	Tablets	Mallinckrodt Inc.	Assay, Dissolution, ID, Related Compounds, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Calfactant	INFASURF (RLD)	Intratracheal Suspension	Ony, Inc.	Test clogging of the tubes under required conditions as well as other experimental conditions to determine cause of clog, particle sizing	Adverse Event	Passed Test
Levetiracetam	Generic	Extended Release Tablets	Teva Pharma	Dissolution	Consumer Complaints	Passed Test
Lidocaine	Generic	Transdermal	Actavis, Inc.	90° peel adhesion to stainless steel, shear adhesion and tack, cold flow	Consumer complaints	Cold Flow Failed, all others Passed
Metformin HCl	Generic	Extended Release Tablets	Amneal Pharmaceuticals	Dissolution, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Metformin HCl	Generic	Extended Release Tablets	Apotex Inc.	Dissolution, CU, WV	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Metformin HCl	Generic	Extended Release Tablets	Inventia Healthcare Private Ltd	Dissolution, CU, WV	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Metformin HCl	Generic	Extended Release Tablets	Mylan Laboratories Limited	Dissolution, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Metformin HCl	Generic	Extended Release Tablets	Sun Pharmaceutical Industries	Dissolution, CU, WV	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Metformin HCl	Generic	Extended Release Tablets	Teva Generics	Dissolution, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Metformin HCl	Generic	Tablets	Alkem Laboratories Ltd	Dissolution, CU, WV	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Metformin HCl	Generic	Tablets	Amneal Pharmaceuticals	Dissolution, CU, WV	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Metformin HCl	Generic	Tablets	Blu Caribe Inc.	Dissolution, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Metformin HCl	Generic	Tablets	Emcure Pharmaceuticals Limited	Dissolution, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Metformin HCl	Generic	Tablets	Glenmark Generics Ltd	Dissolution, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed test
Metformin HCl	Generic	Tablets	Granules India Limited	Dissolution, CU, WV	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Metformin HCl	Generic	Tablets	Sun Pharmaceutical Industries	Assay, Dissolution, ID, Related Compounds, CU, WV	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Metoprolol Succinate	Generic	Extended Release Tablets	Dr. Reddy's Laboratories Ltd	Assay, Impurities, Dissolution, CU	Assess market quality	Passed Test
Metoprolol Tartrate	Generic	Tablets	Emcure Pharmaceuticals Limited	Dissolution, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Metoprolol Tartrate	Generic	Tablets	Ipca Laboratories Limited	Assay, Dissolution, ID, CU, WV, Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Niacin / Simvastatin	SIMCOR (brand)	Extended Release Tablets	Abbvie Inc.	Dissolution, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Pravastatin Sodium	Generic	Tablets	Apotex	Dissolution, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Pravastatin Sodium	Generic	Tablets	Glenmark Generics Ltd	Dissolution, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Pravastatin Sodium	Generic	Tablets	Teva Czech Industries	Dissolution, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Propafenone HCl	RYTHMOL (brand)	Tablets	Halo Pharmaceuticals	Assay, Dissolution, ID, Related Compounds, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Propafenone HCl	Generic	Tablets	Vintage Pharm (Qualitest Pharmaceuticals)	Assay, Dissolution, ID, Related Compounds, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Propranolol HCl	Generic	Tablets	Teva Czech Industries	Assay, Dissolution , CU, WV	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Propranolol HCl and Hydrochlorothiazide	Generic	Tablets	Mylan Pharmaceuticals Inc.	Assay, Dissolution, ID, Related Compounds, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Rituximab	RITUXAN (RLD)	Injection	Genentech	Induction of apoptosis using flow cytometry and two cellular stains	Assess market quality	Passed Test
Simvastatin	Generic	Tablets	Blu Caribe Inc.	Dissolution, CU, WV	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Simvastatin	Generic	Tablets	Lupin Limited	Dissolution, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Simvastatin	Generic	Tablets	Teva Czech Industries	Dissolution, CU, WV	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Tacrolimus	PROGRAF (brand)	Capsules	Astellas Pharma US, Inc.	Assay, Impurities and Dissolution	Assess market quality	Passed Test
Tacrolimus	Generic	Capsules	Sandoz	Assay, Impurities and Dissolution	Assess market quality	Passed Assay and Impurities; Failed Dissolution
Tacrolimus	Generic	Capsules	Dr. Reddy's Laboratories Ltd	Assay, Impurities and Dissolution	Assess market quality	Passed Test
Valsartan	DIOVAN (RLD)	Tablet	Novartis Pharmaceuticals Corporation	Assay, Dissolution, Raman Comparison	Consumer complaint	Passed Test
Valsartan	Generic	Tablet	Teva	Assay, Dissolution, Raman Comparison	Consumer complaint	Passed Test
Valsartan	Generic	Tablet	Ohm Laboratories Inc.	Assay, Dissolution, Raman Comparison	Consumer complaint	Passed Test
Venlafaxine HCl	Generic	Tablets	Dr. Reddy's Laboratories Ltd	Dissolution, CU, WV	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Venlafaxine HCl	Generic	Tablets	Teva Pharm Industries	Dissolution, CU, WV	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Verapamil HCI	CALAN (RLD)	Tablets	G.D. Searle LLC Division of Pfizer Inc.	Dissolution	Assess market quality	Passed Test
Warfarin Sodium	Generic	Tablets	Taro Pharmaceuticals U.S.A., Inc.	IPA Content (GC), Dissolution	Adverse event report	Failed Test
Warfarin Sodium	COUMADIN (brand)	Tablets	Bristol-Myers Squibb	IPA Content (GC), Dissolution	Adverse event report	Passed Test
Warfarin Sodium	Generic	Tablets	Invagen Pharmaceuticals	IPA Content (GC), Dissolution	Adverse event report	Passed Test
Warfarin Sodium	Generic	Tablets	Zydus Pharmaceuticals	IPA Content (GC), Dissolution	Adverse event report	Passed Test

FY 14 Results

FY14 Drugs (PDF - 104KB)

FY14 Active Pharmaceutical Ingredient (PDF - 90KB)

Drug Quality: Postmarket Sampling and Testing Results (FY 2014)

Test results updated bi-annually.

Drug Name	Trade Name	Dosage Form	Firm	Tests Performed	Why Tested	Results
0.9% Sodium Chloride	Generic	Injection	Fresenius Medical Care	Microbiologic (bacterial endotoxin & visual exam; assay, identification (ID) and pH)	Reports of cloudiness	Passed Test
1.5% Dextrose Peritoneal Dialysis Solution	Delflex	Injection	Fresenius Medical Care	Microbiologic (bacterial endotoxin & visual exam; assay, ID and pH)	Reports of cloudiness and discoloration	Passed Test
5% Dextrose Injection USP Mini Bag Plus	Generic	Injection	Baxter Healthcare Corp	Microbiologic (bacterial endotoxin)	Reports of particulates and discoloration	Passed Test
Albuterol Sulfate	Generic	Inhalation Aerosol	Teva Pharmaceuticals	Dose Uniformity	Product was found not to meet specifications during a research study	Passed Test
Amino Acid	Premasol	Injection	Baxter Healthcare Corp	Microbiologic (bacterial endotoxin)	Reports of particulates and discoloration	Passed Test
Amino Acid	Travasol	Injection	Baxter Healthcare Corp	Microbiologic (bacterial endotoxin)	Reports of particulates and discoloration	Passed Test
Amino Acid	Clinisol	Injection	Baxter Healthcare Corp	Microbiologic (bacterial endotoxin)	Reports of particulates and discoloration	Passed Test
Amino Acid	Clinimix	Injection	Baxter Healthcare Corp	Microbiologic (bacterial endotoxin)	Reports of particulates and discoloration	Passed Test
Amino Acid	ProSol	Injection	Baxter Healthcare Corp	Microbiologic (bacterial endotoxin)	Reports of particulates and discoloration	Passed Test
Amino Acid	Clinimix E	Injection	Baxter Healthcare Corp	Microbiologic (bacterial endotoxin)	Reports of particulates and discoloration	Passed Test
Amino acid with electrolytes	Generic	Injection	Baxter Healthcare Corp	Microbiologic (bacterial endotoxin )	Reports of particulates and discoloration and closure defects/leaks	Passed Test
Amoxicillin	Generic	Tablets	Hikma Pharmaceuticals	Assay and impurities	Consumer adverse event complaint	Passed Test
Atorvastatin Calcium	Lipitor	Tablets	Parke-Davis Division of Pfizer Inc.	Dissolution, liquid chromatography-mass spectrometry (LC-MS)	Reports of Impurities	Passed Test
Atorvastatin Calcium	Generic	Tablets	Apotex Corp.	Dissolution, LC-MS	Reports of Impurities	Passed Test
Atorvastatin Calcium	Generic	Tablets	Greenstone	Dissolution, LC-MS	Reports of Impurities	Passed Test
Atorvastatin Calcium	Generic	Tablets	Kremers Urban Pharmaceuticals Inc Kremer	Dissolution, LC-MS	Reports of Impurities	Passed Test
Atorvastatin Calcium	Generic	Tablets	Mylan Pharmaceuticals Inc.	Dissolution, LC-MS	Reports of Impurities	Passed Test
Atorvastatin Calcium	Generic	Tablets	Ranbaxy Pharmaceuticals Inc	Dissolution, LC-MS	Reports of Impurities	Passed Test
Atorvastatin Calcium	Generic	Tablets	Dr. Reddy’s Laboratories Limited	Dissolution, LC-MS	Reports of Impurities	Passed Test
Atorvastatin Calcium	Generic	Tablets	Sandoz Inc.	Dissolution, LC-MS	Reports of Impurities	Passed Test
Bupropion XL	Wellbutrin XL	Tablets	Valeant Pharmaceuticals	Dissolution, assay and impurities	Verify drug quality for a clinical trial	Passed Test
Bupropion XL	Generic	Tablets	Watson Labs	Dissolution, assay and impurities	Verify drug quality for a clinical trial	Passed Test
Bupropion XL	Generic	Tablets	Anchen/Par Pharmaceuticals	Dissolution, assay and impurities	Verify drug quality for a clinical trial	Passed Test
Ciprofloxacin	Generic	Tablets	Dr. Reddy’s Laboratories Limited	Assay, dissolution, ID, weight variation	Recent GMP violations and quality issues such as discoloration and unknown impurities	Passed Tests
Clopidogrel	Generic	Tablets	Dr. Reddy’s Laboratories Limited	Dissolution, assay and impurities	Consumer complaint	Passed Tests
Decitabine	Generic	For Injection	Dr. Reddy’s Laboratories Limited	Microbiologic (bacterial endotoxin)	Recent GMP violations and quality issues sdiscoloration and unknown impurities	Passed Tests
Dobutamine HCl in 5% Dextrose	Generic	Injection	Baxter Healthcare Corp	Microbiologic (bacterial endotoxin)	Reports of particulates and discoloration	Passed test
Dopamine HCl and 5% Dextrose	Generic	Injection	Baxter Healthcare Corp	Microbiologic (bacterial endotoxin)	Reports of particulates and discoloration	Passed Test
Fentanyl	Generic	Transdermal System	Mylan Pharmaceuticals Inc.	Assay, content uniformity, and degradation	Difficult to manufacture; past history violations; stability failure	Passed Tests
Fluconazole USP	Generic	Injection	Baxter Healthcare Corp	Microbiologic (bacterial endotoxin)	Reports of particulates and discoloration	Passed Test
Fluoxetine	Generic	Capsules	Dr. Reddy’s Laboratories Limited	Content uniformity, dissolution, chromatographic purity, ID	Recent GMP violations and quality issues such as discoloration and unknown impurities	Passed Tests
Gabapentin	Gralise	Tablets	Depomed, Inc.	Assay, content uniformity, dissolution, ID, related compounds	Atypical dissolution concerns	Passed Tests
Gentamicin Sulfate in 0.9% Sodium Chloride	Generic	Injection	Baxter Healthcare Corp	Microbiologic (bacterial endotoxin)	Reports of particulates and discoloration	Passed Test
Glimepiride	Generic	Tablets	Dr. Reddy’s Laboratories Limited	Assay, content uniformity, dissolution, related substances, ID	Recent GMP violations and quality issues such as discoloration and unknown impurities	Passed Tests
Heparin Sodium	Generic	Injection	Gland	Contamination	Large percentage of crude, API and finished dose heparin products are tested for contamination as a result of the 2008 heparin crisis	Passed Test
Heparin Sodium	Generic	Injection	Aurobindo	Contamination	Large percentage of crude, API and finished dose heparin products are tested for contamination as a result of the 2008 heparin crisis	Passed Test
Heparin Sodium	Generic	Injection	Hospira	Contamination	Large percentage of crude, API and finished dose heparin products are tested for contamination as a result of the 2008 heparin crisis	Passed Test
Heparin Sodium and 0.9% Sodium Chloride	Generic	Injection	Baxter Healthcare Corp	Microbiologic (bacterial endotoxin)	Reports of particulates and discoloration	Passed Test
Lamotrigine	Generic	Extended Release Tablets	Dr. Reddy’s Laboratories Limited	Content uniformity, dissolution, related substances, ID, weight variation	Recent GMP violations and quality issues such as discoloration and unknown impurities	Passed Tests
Lansoprazole	Generic	Delayed Release Capsules	Dr. Reddy’s Laboratories Limited	Content uniformity, dissolution, related substances, ID, weight variation	Recent GMP violations and quality issues such as discoloration and unknown impurities	Passed Tests
Levothyroxine Sodium	Generic and Trade (Unithroid)	Tablets	Jerome Stevens	Assay, content uniformity, dissolution, impurities, weight variation, & ID	Field Alert and recalls of out-of-specification subpotency results, degradation, discoloration and foreign material complaints	Passed Test
Levothyroxine Sodium	Generic	Tablets	Mylan Pharmaceuticals Inc.	Assay, content uniformity, dissolution, impurities, weight variation, & ID	Field Alert and recalls of out-of-specification subpotency results, degradation, discoloration and foreign material complaints	Passed Test
Levothyroxine Sodium	Tirosint	Capsules	Institut Biochimique Sa, Lugano, Switzerland	Assay, content uniformity, dissolution, impurities, weight variation, & ID	Field Alert and recalls of out-of-specification subpotency results, degradation, discoloration and foreign material complaints	Passed Test
Levothyroxine Sodium	Levoxyl	Tablets	King Legacy (subsidiary of Pfizer)	Assay, content uniformity, dissolution, impurities, weight variation, & ID	Field Alert and recalls of out-of-specification subpotency results, degradation, discoloration and foreign material complaints	Passed Test
Levothyroxine Sodium	Synthroid	Tablets	Knoll LLC/dba Abbott Labs	Assay, content uniformity, dissolution, impurities, weight variation, & ID	Field Alert and recalls of out-of-specification subpotency results, degradation, discoloration and foreign material complaints	Passed Test
Levothyroxine Sodium	Generic	Tablets	Patheon Inc	Assay, content uniformity, dissolution, ID, impurities, poison/toxin screening	Atypical dissolution concerns	Passed Tests
Lidocaine HCl & 5% Dextrose	Generic	Injection	Baxter Healthcare Corp	Sterility & bacterial endotoxin & visual inspection of particulates and container defects	Reports of particulates and discoloration and closure defects/leaks	Passed Test
Loperamide HCl	Imodium A-D	Caplets	Janssen Ortho LLC	Assay, content uniformity, dissolution, ID degradation	Atypical dissolution concerns	Passed Tests
Methotrexate	Generic	Tablets	Mylan Technologies	Assay, content uniformity, dissolution, ID, water content, impurities	Generic product did not seem to work as effectively as trade product	Passed Tests
Methotrexate Sodium	Generic	Tablets	Mylan LLC	Assay, content uniformity, dissolution, impurities & ID	Complaints that generic product does not work as effectively as trade name product	Passed Test
Metronidazole USP	Generic	Injection	Baxter Healthcare Corp	Microbiologic (bacterial endotoxin)	Reports of particulates and discoloration	Passed Test
Milrinone Lactate & 5% Dextrose	Generic	Injection	Baxter Healthcare Corp	Sterility & bacterial endotoxin & visual inspection of particulates and container defects	Reports of particulates and discoloration and closure defects/leaks	Passed Test
Montelukast Sodium	Generic	Tablets	Dr. Reddy’s Laboratories Limited	Content uniformity, dissolution, related substances, ID	Recent GMP violations and quality issues such as discoloration and unknown impurities	Passed Tests
Montelukast Sodium	Generic	Oral Granules	Dr. Reddy’s Laboratories Limited	Content uniformity, dissolution, related substances, ID	Recent GMP violations and quality issues such as discoloration and unknown impurities	Passed Tests
Nateglinide	Generic	Tablets	Dr. Reddy’s Laboratories Limited	Uniformity of dosage units, dissolution, impurities, ID	Recent GMP violations and quality issues such as discoloration and unknown impurities	Passed Tests
Nitazoxanide	Alinia	For Oral Suspension	Patheon Inc	Assay, ID, viscosity, physical appearance	Viscosity and assay out-of-specification results during stability testing	Passed Tests
Nizatidine	Generic	Capsules	Dr. Reddy’s Laboratories Limited	Assay, dissolution ID, related substances	Recent GMP violations and quality issues such as discoloration and unknown impurities	Passed Tests
Olanzapine	Generic	Tablets	Dr. Reddy’s Laboratories Limited	Content uniformity, dissolution, organic impurities, ID, weight variation	Recent GMP violations and quality issues such as discoloration and unknown impurities	Passed Tests
Olanzapine	Generic	Orally disintegrating tablets	Dr. Reddy’s Laboratories Limited	Content uniformity, dissolution, related substances, ID, weight variation	Recent GMP violations and quality issues such as discoloration and unknown impurities	Passed Tests
Potassium Chloride	Generic	Injection	Baxter Healthcare Corp	Microbiologic (bacterial endotoxin)	Reports of particulates and discoloration	Passed Test
Quetiapine Fumarate	Generic	Tablets	Dr. Reddy’s Laboratories Limited	Assay, content uniformity, dissolution, related substances, ID	Recent GMP violations and quality issues such as discoloration and unknown impurities	Passed Tests
Ranitidine Hydrochloride	Generic	Capsules	Dr. Reddy’s Laboratories Limited	Assay, content uniformity, dissolution, ID, related substances	Recent GMP violations and quality issues such as discoloration and unknown impurities	Passed Tests
Ropinirole	Generic	Extended Release Tablets	Dr. Reddy’s Laboratories Limited	Content uniformity, dissolution, related substances	Recent GMP violations and quality issues such as discoloration and unknown impurities	Passed Tests
Sildenafil	Generic	Tablets	Dr. Reddy’s Laboratories Limited	Assay, dissolution, weight variation, uniformity of dosage units, organic impurities, ID	Recent GMP violations and quality issues such as discoloration and unknown impurities	Passed Tests
Sumatriptan Succinate	Generic	Tablets	Dr. Reddy’s Laboratories Limited	Content uniformity, dissolution, related substances, ID	Recent GMP violations and quality issues such as discoloration and unknown impurities	Passed Tests
Tacrolimus	Generic	Capsules	Dr. Reddy’s Laboratories Limited	Content uniformity, dissolution, impurities	Recent GMP violations and quality issues such as discoloration and unknown impurities	Passed Tests
Temozolomide	Temodar	Capsules	MSD Internat'l GmbH	Assay, content uniformity, dissolution, ID, impurities, weight uniformity	Degradation and impurity out-of-specification results during stability testing	Passed Tests

FY 13 Results

FY13 Active Pharmaceutical Ingredient (PDF - 100KB)

Drug Quality: Postmarket Sampling and Testing Results (FY 2013)

Drug Name	Trade Name	Dosage Form	Firm	Tests Performed	Why Tested	Results
Acetaminophen/ Diphenhydramine HCl / Phenylephrine HCl OTC product	Flu Relief Therapy Night Time	Liquid	Aaron Industries Inc.	Microbiologic, assay and identification (ID)	Firm’s method not stability indicating & USP method not verified under actual conditions.	Meets Quality Standards
Albuterol Sulfate	ProAir HFA	Inhalation Aerosol	Teva Respiratory, LLC	Particle size distribution, unit dose uniformity (UDU)	Product tested during a research project did not meet product specs.	Meets Quality Standards
Alprazolam	Xanax	Tablets	Pharmacia & Upjohn Company Division of Pfizer Inc	Assay, Dissolution, ID	Recall in 2012 for stability failures.	Meets Quality Standards
Amlodipine Besylate	Generic	Tablets	Epic Pharma LLC	Assay, ID, UDU, Impurities	Good manufacturing Process (GMP) issues at specific firm.	Meets Quality Standards
Atorvastatin Calcium	Lipitor	Tablets	Parke-Davis Division of Pfizer Inc.	Assay, UDU, Dissolution, ID	Top selling drug.	Meets Quality Standards
Atorvastatin Calcium	Generic	Tablets	Ranbaxy Pharmaceuticals Inc.	Assay, UDU, Dissolution, ID	Firm Top selling drug	Meets Quality Standards
Atorvastatin Calcium	Generic	Tablets	Ranbaxy Pharmaceuticals Inc.	Dissolution	Physician complaint	Meets Quality Standards
Azathioprine	Generic	Tablets	Mylan Pharmaceuticals Inc.	UDU, Dissolution, ID	Process variability issues	Meets Quality Standards
Bismuth Subsalicylate OTC product	Peptic Relief Maximum Strength	Suspension	Aaron Industries Inc.,	Assay, ID, pH; Microbiologic (yeast, mold)	Firm’s method not stability indicating, and USP method not verified under actual conditions	Failed: finding resulted in an inspection in March 2014 Aaron Indus. is now P&L Development
Dextromethorphan Hydrobromide & Guaifenesin OTC product	Tussin Cough & Chest Congestion DM	Liquid	Aaron Industries, Inc.	Assay and impurities; Microbiologic (yeast, mold)	Firm’s method not stability indicating and USP method not verified under actual conditions	Failed: finding resulted in an inspection in March 2014 Aaron Indus. is now P&L Development
Diclofenac Sodium, Misoprostol	Arthrotec	Tablets	G.D. Searle LLC Division of Pfizer Inc,	Assay, UDU, Dissolution, ID	Firm has had CGMP issues (inadequate controls); failure to submit Field Alert Reports	Meets Quality Standards
Epinephrine	Epinephrine	Injection	International Medication Systems	Assay, Clarity, pH, and ID; Microbiologic (sterility)	Important drug (for emergency use) with relatively short shelf life	Meets Quality Standards
Epinephrine	EpiPen	Auto-Injector	Mylan Specialty L.P.	Declared active ingredient; Microbiologic Growth	Important drug (for emergency use) with relatively short shelf life	Meets Quality Standards
Epinephrine	EpiPen Jr	Auto-Injector	Mylan Specialty L.P.	Declared active ingredient; Microbiologic	Important drug (for emergency use) with relatively short shelf life	Meets Quality Standards
Epinephrine	Epinephrine Abboject Syringe	Injection	Hospira, Inc.,	Assay, ID, pH, Color, Clarity	Important drug (for emergency use) with relatively short shelf life	Meets Quality Standards
Estradiol	Vivelle Dot	Transdermal System	Novartis Pharmaceuticals	Assay and ID; Adhesion and Liner Release	MedWatch reports cause general concern about transdermal products - adhesion as well as assay	Meets Quality Standards
Estradiol	Climara	Transdermal System	Bayer HealthCare Pharmaceuticals Inc.	Assay and ID; Peel Adhesion	MedWatch reports cause general concern about transdermal products - adhesion as well as assay	Meets Quality Standards
Estradiol	Generic	Transdermal Patches	Mylan Pharmaceuticals Inc.	Assay and ID; Liner Release, Probe Tack, Adhesion to Steel	MedWatch reports cause general concern about transdermal products - adhesion as well as assay	Meets Quality Standards
Estradiol	Alora	Transdermal System	Watson Laboratories Inc,	Assay and ID; Liner Release, Probe Tack, Adhesion to Steel	MedWatch reports cause general concern about transdermal products - adhesion as well as assay	Meets Quality Standards
Estradiol/ Levonorgestrel	Climara Pro	Transdermal System	Bayer HealthCare Pharmaceuticals Inc.	Assay and ID; Liner release and Peel Adhesion	MedWatch reports cause general concern about transdermal products - adhesion as well as assay	Meets Quality Standards
Norelgestromin and Ethinyl Estradiol	Ortho Evra	Transdermal System	Janssen Pharmaceuticals, Inc.	Assay, UDU, and ID; Liner release and Peel Adhesion	MedWatch reports cause general concern about transdermal products - adhesion as well as assay	Meets Quality Standards
Fentanyl	Generic	Transdermal System	Mallinckrodt Inc.	Assay and ID; Adhesion and Peel Strength	MedWatch reports cause general concern about transdermal products - adhesion as well as assay	Meets Quality Standards
Fentanyl	Generic	Transdermal System	Actavis South Atlantic LLC	Assay and ID; Probe Tack, Shear Adhesion, Adhesion Peel Strength	MedWatch reports cause general concern about transdermal products - adhesion as well as assay	Meets Quality Standards
Fentanyl	Generic	Transdermal System	Mylan Pharmaceuticals Inc,	Assay and ID: Peel Strength from Steel and Liner Release	MedWatch reports cause general concern about transdermal products - adhesion as well as assay	Meets Quality Standards
Finasteride	Generic	Tablets	Mylan Pharmaceuticals Inc,	Assay, UDU, Dissolution	Process variability issues	Meets Quality Standards
Fluoxetine hydrochloride	Generic	Capsules	Aurobindo Pharma USA, Inc.	Dissolution, assay	Tested as part of a research project	Meets Quality Standards
Fluoxetine hydrochloride	Generic	Capsules	Sandoz Inc	Dissolution, assay	Tested as part of a research project	Meets Quality Standards
Fluoxetine hydrochloride	Generic	Capsules	Mylan Pharmaceuticals Inc.	Dissolution, assay	Tested as part of a research project	Meets Quality Standards
Furosemide	Generic	Tablets	Ranbaxy Pharmaceuticals Inc.	Dissolution, assay	Physician complaint	Meets Quality Standards
Gabapentin	Generic	Capsules	Amneal Pharmaceuticals	Assay, UDU and Dissolution	Complaint on missing units during manufacturing	Meets Quality Standards
Gentamicin Sulfate	Generic	In 0.9% Sodium Chloride Injection	Baxter Healthcare Corporation,	pH and ID	GMP issues	Meets Quality Standards
Heparin Sodium	Generic	Injection	Hospira Inc.	Contamination	Large percentage of crude, API and finished dose heparin products are tested for contamination as a result of the 2008 heparin crisis.	Meets Quality Standards
Chlorpheniramine Maleate, Ibuprofen, pseudoephedrine HCl) OTC product	Advil Allergy Sinus	Tablet	Pfizer	UDU, Dissolution, and ID	Process Variability issues	Meets Quality Standards
Ibuprofen OTC product	Advil	Tablet	Pfizer	Assay, UDU, Dissolution and ID	Process Variability issues	Meets Quality Standards
Lamivudine & Zidovudine	Combivir	Capsules	ViiV Healthcare	UDU, Dissolution and ID	GMP Issues with some manufacturers	Meets Quality Standards
Lamivudine & Zidovudine	Generic	Capsules	Teva Pharmaceuticals	Assay, UDU and Dissolution	Warning Letter 3/2010 re: drug contamination & GMP issues; not surveyed before	Meets Quality Standards
Lamivudine	Epivir	Tablets	ViiV Healthcare	Assay, UDU, Dissolution and ID	GMP Issues with some manufacturers	Meets Quality Standards
Lamivudine	Generic	Tablets	Apotex Corp.	Assay, ID, Impurities, and Dissolution	GMP Issues with some manufacturers	Meets Quality Standards
Lamivudine	Generic	Tablets	Aurobindo Pharma USA, Inc.	Assay, Dissolution, UDU and ID	GMP Issues with some manufacturers	Meets Quality Standards
Lenalidomide	Revlimid	Capsules	Celgene Corp.	Assay, UDU and Dissolution	Question post approval controls	Meets Quality Standards
Levothyroxine Sodium	Synthroid	Tablets	Abbvie Inc.	Assay	Physician Complaint	Meets Quality Standards
Levothyroxine Sodium	Generic	Tablets	Alara Pharmaceutical Corporation	Assay	Physician Complaint	Meets Quality Standards
Levothyroxine Sodium	Generic	Tablets	Lannett Company, Inc.	Assay	Physician Complaint	Meets Quality Standards
Levothyroxine Sodium	Generic	Tablets	Mylan Pharmaceuticals Inc.	Assay	Physician Complaint	Meets Quality Standards
Losartan Potassium	Generic	Tablets	Torrent Pharma Inc.	Assay, ID and Impurities	Check assay, impurities, and dissolution. Warning Letter May 2011 re: GMP issues; not surveyed before; widely prescribed;	Meets Quality Standards
Losartan Potassium	Generic	Tablets	Aurobindo Pharma USA, Inc.	Assay, Dissolution, UDU	Consumer Complaint	Meets Quality Standards
Losartan Potassium & Hydrochlorothiazide	Generic	Tablets	Aurobindo Pharma USA, Inc..	Assay, UDU, Dissolution and ID	Check assay, impurities, and dissolution. Warning Letter May 2011 re: GMP issues;	Meets Quality Standards
Methyphenidate	Daytrana	Transdermal System	Noven Therapeutics, LLC	Assay and ID; Shear and Peel Liner Release	MedWatch reports cause general concern about transdermal products - adhesion as well as assay	Meets Quality Standards
Metoprolol Succinate	Toprol XL	Extended Release Tablets	AstraZeneca LP	Dissolution	Physician complaint	Meets Quality Standards
Metoprolol Succinate	Generic	Extended Release Tablets	Dr. Reddy’s Laboratories Limited	Dissolution	Physician complaint	Meets Quality Standards
Metoprolol Succinate	Generic	Extended Release Tablets	Par Pharmaceutical Inc.	Dissolution	Physician complaint	Meets Quality Standards
Metoprolol Succinate	Generic	Extended Release Tablets	Mylan Pharmaceuticals Inc.	Dissolution	Physician complaint	Meets Quality Standards
Metoprolol Succinate	Generic	Extended Release Tablets	Wockhardt USA LLC.	Dissolution	Physician complaint	Meets Quality Standards
Metoprolol Succinate	Generic	Extended Release Tablets	Watson Pharma, Inc.	Dissolution	Physician complaint	Meets Quality Standards
Metoprolol Tartrate	Generic	Extended Release Tablets	Ranbaxy Pharmaceuticals Inc.	Dissolution	Physician complaint	Meets Quality Standards
Olanzapine	Generic	Tablets	Dr. Reddy’s Laboratories Limited	UDU, Dissolution and ID	Top selling drug;	Meets Quality Standards
Oxycodone HCl	Generic	Tablets	Caraco Pharmaceutical Laboratories, Ltd.	Assay, UDU and ID Dissolution	Complaints questioning potency	Meets Quality Standards
Oxybutynin	Oxytrol	Transdermal System	Actavis	Assay, ID, adhesion	MedWatch reports cause general concern about transdermal products - adhesion as well as assay	Meets Quality Standards
Protamine Sulfate	Generic	Injection	APP Pharmaceuticals LLC,	Assay, impurities	Response to adverse events	Meets Quality Standards
Tacrolimus	Generic	Capsules	Mylan Pharmaceuticals Inc.	Assay, Crystallinity, Dissolution, ID	Process validation issues	Meets Quality Standards
Temozolomide	Temodar	Capsules	Merck Sharp & Dohme Corp., a subsidiary of MERCK & CO., INC.,	Assay, UDU, Dissolution and ID	Process variability issues	Meets Quality Standards
Torsemide	Generic	Tablets	Teva Pharm	Dissolution, Assay	Physician complaint	Meets Quality Standards
Valacyclovir HCl	Generic	Tablets	Aurobindo Pharma USA, Inc.	Assay, UDU, Dissolution and ID	GMP issues: survey of several manufacturers was performed	Meets Quality Standards
Venlafaxine HCl	Generic	Extended Release Capsules	Aurobindo Pharma USA, Inc.	Assay, UDU, Dissolution and ID	GMP issues: survey of several manufacturers was performed	Meets Quality Standards
Venlafaxine HCl	Generic	Extended Release Tablets	Kremers Urban	Assay, UDU, Dissolution, ID and Related Compounds	GMP issues: survey of several manufacturers was performed	Meets Quality Standards
Venlafaxine HCl	Generic	Extended Release Capsules	Wockhardt USA LLC	Assay, UDU, Dissolution and ID	GMP issues: survey of several manufacturers was performed	Meets Quality Standards
Warfarin Sodium	Coumadin	Tablets	Bristol-Myers Squibb Company	UDU, Dissolution and ID	Past recalls raise concerns that product may not conform to shelf life	Meets Quality Standards
Zolpidem Tartrate	Generic	Tablets	Torrent Pharma Inc.	Assay and ID	Missing units from manufacturing	Meets Quality Standards

Additional Resources

• CDER Conversation: CDER’s Drug Quality Sampling and Testing program
• Generic Drugs Undergo Rigorous FDA Scrutiny
• Quality of New Domestic Hand Sanitizer Drug Product Manufacturers During COVID‑19

How to Contact FDA

Division of Drug Information

For general drug-related questions:

• Telephone: 855-543-3784 or 301-796-3400
• Email: druginfo@fda.hhs.gov

Alerting FDA to Potential Safety or Quality Issues

If you are concerned about a drug product or have experienced an adverse event from a medication, please tell your health care professional. Health care professionals and consumers are encouraged to report adverse events or quality problems experienced with the use of a product to FDA's MedWatch Safety Information and Adverse Event Reporting program:

• Complete and submit the report online at www.fda.gov/medwatch/report.htm
• Download and complete the form, then submit it via fax at 1-800-FDA-0178

FDA uses these reports to track potential public health risks and compare our scientific data with the information we receive to determine if further actions and analyses are necessary.

Request Information through FDA's Freedom of Information Office

If you cannot find the information you are looking for using FDA’s search function, you can make an information request under the U.S. Freedom of Information Act (FOIA). Such documents are not prepared specifically for public distribution, but are available upon specific written request. For more information:

• How to make an FOIA request
• Submit a FOIA request online