Inspections, Recalls, and Other Actions with Respect to Firms that Engage in Animal Drug Compounding

Some pharmacies listed here were cited for violations of the FD&C Act relating to their human drug compounding practices but make both human and animal drugs.

Abbott's Compounding Pharmacy Inc., Berkeley, CA

• Firm Press Release: Abbott's Compounding Pharmacy Issues Voluntary Recall of All Lots of Unexpired Sterile Human and Animal Compounded Products Due to Lack of Sterility Assurance (01/16/2016)
• CVM Recall Initiation Date: 01/15/2016
• 483 Issued 01/08/2016 (PDF - 2MB)

Absolute Veterinary Compounding Pharmacy – Out of Business, (see Nexgen Pharmaceuticals, LLC), Weatherford, TX

• FMD-145 Letter Issued 02/01/2021 (PDF - 177KB)
• 483 Issued 06/17/2017 (PDF – 754KB)
• CVM Recall Initiation Date: 02/28/2017

Alwan's Pharmacy (see American Pharmacy of Illinois, Inc.), Peoria, IL

American Pharmacy of Illinois, Inc., (dba Alwan's Pharmacy), Peoria, IL

• 483 Issued 07/17/2018 (PDF - 988KB)
• Warning Letter (07/22/2016)
• Amended 483 Issued 11/17/2015 (PDF - 1.4MB)
• 483 Issued 10/28/2015 (PDF - 1.4MB)

Americare Compounding, LLC, Garden City South, NY

• Referral Letter to the New York State Board of Pharmacy Issued 03/22/2017 (PDF - 223KB)
• 483 Issued 06/22/2015 (PDF - 903KB)
• Warning Letter (04/22/2014)
• 483 Issued 06/19/2013 (PDF – 754KB)

Anderson Compounding Pharmacy, Inc. (dba Anderson Compounding Pharmacy), Bristol, TN

• FMD-145 Letter Issued 02/18/2022
• Warning Letter (01/13/2020)
• 483 Issued 04/05/2019 (PDF - 1.09MB)
• CVM Recall Initiation Date: 04/02/2019

APS Pharmacy, (see Drug Depot, Inc.), Palm Harbor, FL

Atlas Pharmaceuticals, LLC, Phoenix, AZ 

• FMD-145 Letter Issued 05/03/2022
• 483 Issued 06/11/2021 (PDF – 860 KB)
• CVM Recall Initiation Date: 06/16/2021
• Warning Letter (09/11/2018)
• 483 Issued 09/26/2017 (PDF - 2.8MB)

Axium Healthcare Pharmacy (dba Balanced Solutions Compounding), Lake Mary, FL

• Warning Letter (07/16/2013)
• 483 Issued 3/15/2013 (PDF - 638KB)
• Firm Press Release - recall of all sterile drug products: Balanced Solutions Compounding Pharmacy, LLC. Announces a Voluntary Nationwide Recall of All Sterile Compounded Products Due to a Lack of Sterility Assurance (04/17/2013)
• FDA Press Release: FDA Announces Voluntary Nationwide Recall by Balanced Solutions Compounding Pharmacy (04/21/2013)

Balanced Solutions Compounding, Lake Mary, FL (see Axium Healthcare Pharmacy)

Beacon Hill Medical Pharmacy, P.C. (dba Rxtra Solutions), Southfield, MI

• Firm Press Release - recall of all sterile drug products: Beacon Hill Medical Pharmacy, P.C. (dba Rxtra Solutions) Issues Voluntary Nationwide Recall of Certain Sterile Products Due to a Question of Sterility Assurance (7/31/2013)
• CVM Recall Initiation Date: 7/26/2013
• 483 Issued 7/19/2013 (PDF – 2.7MB)

Bedford Pharmacy, Inc., (dba Mytilini Enterprises LLC), Bedford, NH

• Firm response to 483 dated 09/22/2017 (PDF - 1MB)
• 483 Issued 08/17/2017 (PDF - 953KB)
• Warning Letter (05/18/2016)
• 483 Issued 08/28/2015 (PDF - 776KB)
• CVM Recall Initiation Date: 09/22/2015

College Pharmacy Incorporated, Colorado Springs, CO

• 483 Issued 01/17/2018 (PDF - 1MB)
• 483 Issued 05/28/2015 (PDF - 1MB)
• 483 Issued 3/15/2013 (PDF - 1.3MB)

Colonia Care Pharmacy, Colonia, NJ

• Firm Response to 483 Issued 08/17/2021 (PDF - 718KB)
• CVM Recall Initiation Date: 07/24/2019
• 483 Issued 04/29/2019 (PDF - 601KB)
• Firm Response to 483 Issued 07/25/2016 (PDF - 969KB) 
• Issued 04/15/2016 (PDF - 708KB)

The Compounding Shop, St. Petersburg, FL – Out of Business

• Warning Letter (08/12/2014)
• 483 Issued 09/03/2013 (PDF - 97KB)
• FDA Press Release: FDA alerts health care providers of lack of sterility assurance of drug products from The Compounding Shop (5/8/2013)
• Firm Press Release - recall of all sterile drug products: In Cooperation with FDA, The Compounding Shop, LLC Declares a Voluntary Recall of All Lots of Sterile Compounded Products Due to a Lack of Sterility Assurance Distributed Within its Local Market Area (05/06/2013)
• Amended 483 Issued 03/25/2013 (PDF - 10MB)
• 483 Issued 03/22/2013 (PDF - 1.3MB)

Creative Compounds (see Oregon Compounding Centers, Inc.), Wilsonville, OR

Diamondback Drugs of Delaware, LLC, (Wedgewood Pharmacy), Scottsdale, AZ

• CVM Recall Initiation Date: 06/10/2013
• 483 Issued 05/17/2013 (PDF - 1.1MB)

Downing Labs, LLC (formally NuVision Pharmacy), Dallas, TX – Out of Business

• FMD-145 Letter Issued 08/06/2019 (PDF - 74KB)
• 483 Issued 11/19/2018 (PDF - 416KB)
• 483 Issued 10/09/2015 (PDF - 8.9MB)
• FDA Requested Recall Letter Issued 09/09/2014 (PDF – 941KB)
• FDA News Release: FDA reminds health care professionals and consumers not to use sterile products from Downing Labs/NuVision Pharmacy of Texas (09/09/2014)
• FDA alerts health care professionals not to use sterile drugs from Downing Labs (aka NuVision Pharmacy) (07/18/2014)
• 483 Issued 07/16/2014 (PDF - 2.1MB)
• FDA Press Release: FDA reminds health care providers not to use sterile products from NuVision Pharmacy (08/16/2013)
• FDA Requested Recall Letter Issued 07/26/2013 (PDF – 862KB)
• FDA Press Release: FDA expands alert to health care providers about lack of sterility assurance of all sterile drug products from NuVision Pharmacy (05/18/2013)
• 483 Issued 04/17/2013 (PDF - 1.2MB)
• Firm Press Release - recall of all sterile drug products: NuVision Pharmacy Recalls All Lots of All Lyophilized Products Compounded by NuVision (04/15/2013)

Drug Depot, Inc., (dba APS Pharmacy), Palm Harbor, FL

• FDA Press Release: FDA alerts customers to voluntary recall of compounded drugs due to sterility issues by Drug Depot, LLC, dba APS Pharmacy (04/26/2022)
• CVM Recall Initiation Date: 03/25/2022
• FMD-145 Letter Issued 09/20/2019 (PDF - 63KB)
• 483 Issued 07/13/2018 (PDF - 272KB)
• 483 Issued 01/22/2016 (PDF - 1.7MB)

Essential Wellness Pharma, (see Kalman Health & Wellness Inc.), Peoria, IL

Fallon Wellness Pharmacy, L.L.C., Latham, NY

• 483 Issued 12/06/2016 (PDF – 1.6MB)
• CVM Recall Initiation Date: 03/29/2016
• 483 Issued 03/10/2015 (PDF - 1MB)

First Royal Care Co. LLC, (dba Red Mountain Compounding Pharmacy), Mesa, AZ

Franck's Compounding Lab, (see Franck's Lab, Inc.), Ocala, FL – Out of Business

Franck's Lab, Inc., Ocala, FL (dba Franck's Compounding Lab) – Out of Business

• FDA Press Release: Federal judge enters order of permanent injunction against Paul W. Franck (04/29/2016)
• Warning Letter (07/09/2012)
• Firm Press Release: All Sterile Human and Veterinary Prescriptions Distributed by Franck's Pharmacy from November 21, 2011 to May 21, 2012 (05/25/2012)
• CVM Recall Initiation Date: 05/21/2012
• CVM Recall Initiation Date: 05/22/2012

FVS Holdings, Inc. (dba Green Valley Drugs), Henderson, NV – Out of Business

• Warning Letter (08/30/2013)
• Firm Press Release - recall of all sterile drug products: Green Valley Drugs Announces Voluntary Nationwide Recall of All Lots of All Sterile Products Compounded, Repackaged, and Distributed by Green Valley Drugs Due to Quality Control Concerns (04/05/2013)
• 483 Issued 03/15/2013 (PDF - 4.9MB)

Grandpa's Compounding Pharmacy, Inc., Placerville, CA – Out of Business

• 483 Issued 09/18/2015 (PDF - 322KB)
• Warning Letter (05/02/2014)
• 483 Issued 09/10/2013 (PDF - 1.1MB)

Green Valley Drugs, (see FVS Holdings, Inc.), Henderson, NV – Out of Business

Health Innovations Pharmacy, Inc., Southern Pines, NC

• FMD-145 Letter Issued 04/21/2018 (PDF - 55KB)
• Warning Letter (07/08/2016)
• 483 Issued 02/27/2015 (PDF - 805KB)
• CVM Recall Initiation Date: 02/12/2015

Health Solutions Pharmacy Center, Inc., (dba Pet Pharmacy NW LLC), Corvallis, OR

Hiers Enterprises, LLC, (see Northwest Compounding Pharmacy), Roseburg, OR

Home Intensive Care Pharmacy, Inc., San Antonio, TX

• Referral Letter to the Texas State Board of Pharmacy Issued 05/05/2016 (PDF - 481KB)
• Amended 483 Issued 05/05/2015 (PDF - 1.3MB)
• 483 Issued 05/05/2015 (PDF - 1.2MB) 
• Warning Letter (01/22/2014)
• 483 Issued 03/01/2013 (PDF - 1.1MB)

IV Solutions of Lubbock, (see Maxor National Pharmacy Services Corporation), Lubbock, TX

• Referral Letter to the Texas Board of Pharmacy Issued 03/18/2014 (PDF - 604KB)
• 483 Response Dated 04/02/2013 (PDF - 976KB)
• 483 Issued 03/20/2013 (PDF - 3.7MB)

I.V. Specialty, Ltd., Austin, TX

• 483 Issued 07/28/2017 (PDF - 594KB)
• FDA Statement: FDA alerts health care professionals and patients not to use human and animal sterile drug products produced and distributed by I.V. Specialty, Ltd., Austin, Texas (03/09/2016)
• 483 Issued 02/05/2016 (PDF - 1.5MB)
• Warning Letter (04/21/2015)
• 483 Issued 07/22/2014 (PDF - 1019KB

JD & SN Inc., (dba Moses Lake Professional Pharmacy), Moses Lake, WA

• FMD-145 Letter Issued 08/09/2018 (PDF - 46KB)
• State Referral Letter Dated 08/09/2018 (PDF - 60KB)
• 483 Issued 07/12/2017 (PDF - 522KB)
• Firm Press Release: Moses Lake Professional Pharmacy Issues Voluntary Recall of Unexpired Sterile Human and Veterinary Compounded Drugs Due to Lack of Sterility Assurance (07/24/2015)
• CVM Recall Initiation Date: 07/24/2015

Kalman Health & Wellness, Inc., (dba Essential Wellness Pharma), Peoria, IL

• Referral Letter to the Illinois State Board of Pharmacy Issued 09/11/2019 (PDF - 118KB)
• FMD-145 Letter Issued 09/11/2019 (PDF - 84KB)
• 483 Issued 06/27/2018 (PDF - 201KB)
• CVM Recall Initiation Date: 09/03/2015
• 483 issued 07/21/2015 (PDF 1.6MB)

Key Pharmacy and Compounding Center (see Puget Sound Drug Corporation), Federal Way, WA

KRS Global Biotechnology, Inc. Boca Raton, FL

• Amended 483 Issued 08/20/2019 (PDF - 2.51MB)
• Firm Recall Announcement: KRS Global Biotechnology, Inc. Issues Voluntary Nationwide Recall of All Human and Animal Sterile Drug Products Due to Lack of Assurance of Sterility (09/12/2019)
• CVM Recall Initiation Date: 09/12/2019
• CVM Recall Initiation Date: 11/16/2017
• 483 Issued 10/23/2017 (PDF - 705KB)
• 483 Issued 08/31/2016 (PDF - 2.2MB)
• 483 Issued 03/17/2014 (PDF – 735KB)

Lowlite Investments, Inc. (dba Olympia Pharmacy), Orlando, FL

• Warning Letter (02/18/2014)
• Firm Press Release - recall of all sterile drug products: Lowlite Investments, Inc. d/b/a Olympia Pharmacy Announces a Voluntary Multi-State Recall of All Sterile Compounded Products Compounded Between December 17, 2012, and March 27, 2013, Due to Concerns about Sterility Assurance (05/29/2013)
• 483 Issued 03/21/2013 (PDF - 717KB)

Lowlyn Pharmacies, Inc. (dba Red Cross Drug), Blanchard, OK

• Referral Letter to Oklahoma State Board of Pharmacy Issued 02/25/2014 (PDF - 2.4MB)
• 483 Issued 03/08/2013 (PDF - 732KB)

Martin Avenue Pharmacy, Inc., Naperville, IL

• Warning Letter (03/18/2015)
• CVM Recall Initiation Date: 09/02/2014
• Firm Press Release - recall of all sterile drug products: Martin Avenue Pharmacy, Inc., Issues a Voluntary Multi-State Recall of All Compounded Sterile Preparations Due to a Lack of Assurance of Sterility (08/27/2014)
• 483 Issued 07/21/2014 (PDF - 1.8MB)

Maxor National Pharmacy Services Corporation, (see IV Solutions of Lubbock), Lubbock, TX

Medcare Pharmacy, Inc., Indian Trail, NC

• CVM Recall Initiation Date: 05/10/2019

The Medicine Shoppe Pharmacy, Port Charlotte, FL

• 483 Issued 03/16/2020 (PDF 1.07 MB)
• CVM Recall Initiation Date: 03/23/2020
• CVM Recall Initiation Date: 04/06/2020

MedPark Pharmacy, LLC, Annapolis, MD

• CVM Recall Initiation Date: 06/01/2017
• 483 Issued 03/10/2017 (PDF - 550KB)

Med Shop Total Care, Inc., Longview, TX

• 483 Issued 07/27/2021 (PDF - 9.94KB)
• Warning Letter (07/30/2019)
• 483 Issued 11/01/2018 (PDF - 2.44MB)

Midwest Compounders Pharmacy, Lenexa, KS

• CVM Recall Initiation Date: 03/11/2015

Montana Compounding Pharmacy P.C., (dba Montana Compounding Pharmacy and Wellness Center), Missoula, MT

• FMD-145 Letter Issued 02/01/2022
• 483 Issued 09/22/2021 (PDF -1.04MB)
• Warning Letter (05/09/2018)
• CVM Recall Initiation Date: 10/24/2016
• 483 Issued 09/20/2016 (PDF - 518KB)
• Warning Letter (12/11/2015)
• CVM Recall Initiation Date: 05/15/2015
• 483 Issued 05/08/2015 (PDF - 2.5MB)

Moses Lake Professional Pharmacy, (see JD & SN Inc.), Moses Lake, WA

Mytilini Enterprises LLC, (see Bedford Pharmacy, Inc.), Bedford, NH

Nature's Pharmacy and Compounding Center, Asheville, NC – Out of Business

• Warning Letter (05/09/2014)
• 483 Issued 11/22/2013 (PDF - 1MB)
• Firm Press Release - recall of all sterile drug products:  Nature's Pharmacy and Compounding Center Issues Voluntary Recall of All Sterile Compounded Products Distributed Within North Carolina Due to Lack of Sterility Assurance (11/13/2013)
• CVM Recall Initiation Date: 11/01/2013

Nexgen Pharmaceuticals, LLC (see Absolute Veterinary Compounding Pharmacy), Weatherford, TX 

• FMD-145 Letter Issued 02/01/2021 (PDF - 177KB)

Nora Apothecary and Alternative Therapies, Inc., (dba Rx Compounding Inc.), Indianapolis, IN

• Amended 483 Issued 09/16/2016 (PDF - 652KB)
• 483 Response Dated 09/06/2016 (PDF - 1.2MB)
• 483 Issued 08/19/2016 (PDF - 626KB)
• 483 Issued 08/21/2014 (PDF - 422KB)
• Warning Letter (02/14/2014)
• Firm Press Release - recall of all sterile drug products: Nora Apothecary & Alternative Therapies Announces a Voluntary Multi-State Recall of All Sterile Compounded Products Due to a Lack of Sterility Assurance (04/22/2013)
• CVM Recall Initiation Date: 04/22/2013
• 483 Issued 03/21/2013 (PDF - 309KB)

Northwest Compounding Pharmacy, (see Hiers Enterprises, LLC), Roseburg, OR

• 483 Issued 11/10/2021 (PDF - 1.1MB)
• CVM Recall Initiation Date: 01/02/2019
• 483 Issued 11/14/2018 (PDF - 1.57MB)

NuVision Pharmacy, Dallas TX (see Downing Labs, LLC) – Out of Business

Oakdell Pharmacy, Inc., San Antonio, TX

• State Referral Letter Issued 12/21/2017 (PDF - 80KB)
• FMD-145 Letter Issued 12/21/2017 (PDF - 66KB)
• 483 Issued 03/29/2017 (PDF - 422KB)
• Warning Letter (05/27/2014)
• 483 Issued 03/01/2013 (PDF - 1.1MB)

Olympia Pharmacy, (see Lowlite Investments, Inc.), Orlando, FL

Oregon Compounding Centers, Inc. (dba Creative Compounds), Wilsonville, OR – Out of Business 

• Warning Letter (01/27/2015)
• Firm Press Release: Oregon Compounding Centers, Inc. Issues Voluntary Recall of Unexpired Sterile Products in Oregon and Washington Due to Lack of Sterility Assurance (10/09/2014)
• 483 Response Dated 10/01/2014 (PDF - 5MB)
• Amended 483 Issued 09/12/2014 (PDF - 1.9MB)
• 483 Issued 8/28/2014 (PDF - 1.7MB)
• CVM Recall Initiation Date: 10/6/2014

Park Compounding, (see South Coast Specialty Compounding, Inc.), Irvine, CA

The Pet Apothecary LLC, Milwaukee, WI

• CVM Recall Initiation Date: 10/19/2018
• 483 Issued 08/07/2018 (PDF - 1.14MB)
• CVM Recall Initiation Date: 10/20/2017

Pet Pharmacy NW LLC, (formerly Health Solutions Pharmacy Center dba Professional Compounding Pharmacy), Corvallis, OR

• CVM Recall Initiation Date: 02/21/2019
• 483 Issued 01/28/2019 (PDF - 1.3MB)

Pharmacy Creations, Randolph, NJ

• 483 Issued 09/30/2015 (PDF - 368KB)
• Firm Press Release: Pharmacy Creations Issues Voluntary Recall of Four Product Lots With Limited Distribution in Florida, New Jersey, New York, and Puerto Rico Due to Potential Non-Sterility (09/04/2014)
• Warning Letter (06/23/2014)
• 483 Response Dated 09/03/2013 (PDF - 39KB)
• 483 Issued 08/19/2013 (PDF - 1.3MB)
• CVM Recall Initiation Date: 03/16/2015

Pharmacy Innovations, Erie, PA

• CVM Recall Initiation Date: 12/28/2022

Pharmacy Plus, Inc., (dba Vital Care Compounder), Hattiesburg, MS

• 483 Issued 05/16/2019 (PDF - 786KB)
• 483 Issued 07/07/2016 (PDF - 1.5MB)
• CVM Recall Initiation Date: 10/07/2022

Pine Pharmacy and Home Care Products Center, Inc., (dba Pine Pharmacy), Williamsville, NY

• FMD-145 Letter Issued 04/25/2019 (PDF - 104KB)
• Referral Letter to New York State Board of Pharmacy Issued 11/07/2016 (PDF - 431KB)
• 483 Issued 04/18/2016 (PDF - 850KB)
• 483 Issued 12/16/2013 (PDF – 5.3MB)
• 483 Issued 07/19/2013 (PDF – 1.4MB)

Portage Pharmacy, Inc., Portage, MI

• Referral Letter to Michigan Board of Pharmacy Issued 2/25/2014 (PDF - 357KB)
• 483 Issued 3/6/2013 (PDF - 8.9MB)

Precision Equine, LLC, Bakersfield, CA.

• Untitled Letter Issued 07/30/2024 (PDF 354 KB)
• 483 Issued 09/26/2023 (PDF – 2.4MB)
• Firm response to 483 dated 10/16/2023 (PDF - 1.4MB)

Premier Pharmacy Labs, Inc., (dba Rx Nations), Weeki Wachee, FL – Out of Business

• FDA Press Release: Federal Court Enters Consent Decree Against Florida Compounder, Prohibiting Manufacture and Distribution of Drugs Due to Insanitary Conditions (09/17/2021)
• 483 Issued 07/25/2019 (PDF - 3.63MB)
• Firm Press Release: Premier Pharmacy Labs Issues Voluntary Nationwide Recall of all Unexpired Sterile Drug Product Lots Due to Lack of Sterility Assurance (06/18/2019)
• CVM Recall Initiation Date: 06/17/2019

Prescription Alternatives, Inc., Frisco, CO

• 483 Issued 11/16/2018 (PDF - 3.8MB)
• CVM Recall Initiation Date: 11/15/2018

The Prescription Center, Fayetteville, NC

• FDA Press Release: FDA alerts health care professionals and patients not to use products from the Prescription Center pharmacy in Fayetteville, N.C. (04/02/2015)
• NCBOP Press Release: North Carolina Board of Pharmacy Announces a Recall of All Lots of Non‐ Sterile and Sterile Products Compounded, Repackaged, and Distributed by Prescription Center Between September 10, 2014 and March 10, 2015 Due to Lack of Sterility, Potency, and Stability Assurance (04/01/2015)

Professional Compounding (see Pet Pharmacy NW LLC formerly Health Solutions Pharmacy Center), Corvallis, OR

Puget Sound Drug Corporation (dba Key Pharmacy and Compounding Center), Federal Way, WA

• 483 Issued 06/13/2019 (PDF - 1.27MB)
• CVM Recall Initiation Date: 04/18/2017
• 483 Issued 03/08/2017 (PDF - 1.9MB)

Ranier’s Rx Laboratory, (formerly Ranier’s Compounding Laboratory, Inc.) Jeannette, PA

• 483 Issued 08/16/2021 (PDF - 1.03MB)
• FDA Press Release: Federal court enters consent decree against Ranier's Rx Laboratory and owner for manufacturing purportedly sterile drug products in unsanitary conditions (02/06/2019)
• FDA Statement: FDA announces Ranier’s Rx Laboratory’s voluntary recall of all sterile compounded drug (07/31/2018)
• FDA Statement: FDA alerts health care professionals, patients, veterinarians and animal owners not to use sterile drug products from Ranier’s Compounding Laboratory (07/10/2018)
• CVM Recall Initiation Date: 7/27/2018
• 483 Issued 05/22/2018 (PDF - 1MB)
• 483 Issued 04/22/2016 (PDF - 1023KB)

Rapid Equine Solutions, LLC, Aston, PA – Out of Business

• Warning Letter (06/12/2020) 
• CVM UPDATE: Compounded Unapproved Animal Drugs from Rapid Equine Solutions Linked to Three Horse Deaths (07/23/2019)
• CVM Recall Initiation Date: 05/24/2019

Red Cross Drug, (see Lowlyn Pharmacies, Inc.), Blanchard, OK

Red Mountain Compounding Pharmacy, (see First Royal Care Co. LLC), Mesa, AZ

• CVM Recall Initiation Date: 08/13/2021
• 483 Issued 08/11/2021 (PDF - 1.7MB)
• Warning Letter (09/08/2020)
• CVM Recall Initiation Date: 8/06/2019
• 483 Issued 06/14/2019 (PDF - 1.37MB)

Reliable Rexall-A Compounding Pharmacy, San Francisco, CA

• Amended 483 Issued 04/20/2016 (PDF - 2MB)
• FDA Statement: FDA announces voluntary recall of all unexpired human and animal compounded drug products produced by Reliable Drug Pharmacy, San Francisco (03/30/2016)
• 483 Issued 03/29/2016 (PDF - 2MB)
• Firm Press Release: Reliable Drug Recall of all Compounded Medications Due to a Potential for Mislabeling and Lack of Quality Assurance (03/25/2016)

Rx Compounding, (see Nora Apothecary and Alternative Therapies, Inc.), Indianapolis, IN

Rx Nations, (see Premier Pharmacy Labs, Inc.), Weeki Wachee, FL

RXQ Compounding, LLC, Athens, OH

• Firm Press Release: RXQ Compounding, LLC Issues Voluntary Nationwide Recall of All Sterile Products within Expiry and Voluntarily Cessation of Production Due to the Lack of Sterility Process Assurance (06/18/2019)
• 483 Issued 06/06/2019 (PDF - 3MB)
• 483 Issued 08/08/2017 (PDF - 1.3MB)
• 483 Issued 09/21/2015 (PDF - 1006KB)

Rxtra Solutions, (see Beacon Hill Medical Pharmacy, P.C.), Southfield, MI

South Coast Specialty Compounding, Inc., (dba Park Compounding), Irvine, CA

• Amended 483 Issued 03/14/2016 (PDF - 1.7MB)
• 483 Issued 03/14/2016 (PDF - 1.9MB)
• Referral Letter to the California State Board of Pharmacy Issued 06/23/2015 (PDF - 985KB)
• CVM Recall Initiation Date:4/23/2015
• 483 Issued 07/02/2014 (PDF - 708KB)

Specialty Compounding, LLC, Cedar Park, TX

• 483 Issued 05/05/2015 (PDF - 418KB)
• CVM Update: Federal Judge enters Consent Decree against Specialty Compounding LLC
  Cedar Park, TX. (03/11/ 2015)
• 483 Issued 9/13/2013 (PDF - 9MB)
• Firm Press Release - recall of all sterile drug products: Specialty Compounding, LLC Issues Nationwide Voluntary Recall of All Lots of Unexpired Sterile Products Due to Reports of Adverse Events (08/15/2013)
• CDC Health Advisory: Nationwide Voluntary Recall of All Products for Sterile Use from Compounding Pharmacy located in Cedar Park, Texas (08/14/2013)
• FDA Press Release: FDA announces nationwide voluntary recall of all products for sterile use from Specialty Compounding (08/11/2013)
• 483 Issued 03/22/13 (PDF – 744KB)

Specialty Medicine Compounding Pharmacy, P.C., South Lyon, MI

• 483 Issued 11/05/2013 (PDF - 3.2MB)
• CVM Recall Initiation Date: 10/19/2013
• Firm Press Release - Recall of Certain Unexpired Compounded Sterile Products: Specialty Medicine Compounding Pharmacy Issues Voluntary Recall of Certain Unexpired Compounded Sterile Products (10/19/ 2013)

Stewart Pharmaceuticals, Inc., (dba Stewart Compounding Pharmacy), Fayetteville, NC

• 483 Issued 02/26/2014 (PDF - 1.4MB)
• Warning Letter (08/21/2013)
• 483 Issued 03/25/2013 (PDF - 7.3MB)

Stokes Healthcare Inc., (dba Stokes Pharmacy), Mount Laurel, NJ

• 483 Issued 10/09/2020 (PDF - 603KB)
• Firm Press Release: Stokes Healthcare Inc. Issues Voluntary Nationwide Recall of Pilocarpine 0.1% Ophthalmic Solution Due to a High Level of Preservative (03/13/2019)
• CVM Recall Initiation Date: 12/03/2018
• 483 Issued 07/02/2018 (PDF - 569KB)
• Referral Letter to the New Jersey State Board of Pharmacy Issued 01/03/2017 (PDF - 421KB)
• Closeout Letter Issued 08/31/2016 (PDF - 263KB)
• 483 Response Dated 04/01/2016 (PDF - 2.2MB)
• 483 Issued 02/12/2016 (PDF - 497KB)

Triangle Compounding, Cary, NC

• FMD-145 Issued 6/17/2020 (PFD-91KB)
• 483 Issued 07/13/2017 (PDF - 2.2MB)
• 483 Issued 01/16/2015 (PDF - 484KB)
• 483 Issued 09/22/2014 (PDF - 1MB)
• Warning Letter (01/14/2014)
• 483 Issued 03/01/2013 (PDF - 880KB)

University Pharmacy, Inc., Salt Lake City, UT

• Referral Letter to Utah State Board of Pharmacy Issued 02/20/2014 (PDF - 240KB)
• 483 Issued 02/26/2013 (PDF - 645KB

US Compounding Inc., Conway, AR

• CVM Recall Initiation Date: 6/01/2021
• CVM Recall Initiation Date: 7/01/2020
• CVM Recall Initiation Date: 7/01/2020
• CVM Recall Initiation Date: 3/25/2020
• CVM Recall Initiation Date: 2/07/2020
• 483 Issued 02/07/2019 (PDF - 2.11MB)
• 483 Issued 07/15/2016 (PDF - 1.4MB)
• Firm Press Release: US Compounding, Inc. Issues Voluntary Nationwide Recall of All Sterile Compounded Products (09/21/2015)
• CVM Recall Initiation Date: 09/12/2015
• 483 Issued 08/21/2015 (PDF - 2.3MB)
• CVM Recall Initiation Date: 07/17/2015
• 483 Issued 03/27/2014 (PDF – 1.1MB)

Veterinary Pharmacy Corporation, Saint Peter, MN

• CVM Recall Initiation Date: 03/22/2016

Vital Care Compounder, (see Pharmacy Plus, Inc.), Hattiesburg, MS

Weatherford Compounding Pharmacy, LLC, Weatherford, TX

• 483 Issued 02/03/2012 (PDF - 460KB)

Wedgewood Village Pharmacy, Inc. Swedesboro, NJ

• CVM Recall Initiation Date: 12/15/2022
• CVM Recall Initiation Date: 07/05/2022
• 483 Issued 03/24/2022 (PDF – 2.44 MB)
• CVM Recall Initiation Date: 02/21/2022
• CVM Recall Initiation Date: 09/2/2016
• 483 Response Dated 10/20/2015 (PDF - 1.1MB)
• Amended 483 Issued 09/30/2015 (PDF - 1.1MB)
• 483 Issued 09/29/2015 (PDF - 1.3MB)
• Warning Letter (02/21/2014)
• 483 Issued 02/11/2013 (PDF - 10.9MB)
• CVM Recall Initiation Date: 03/21/2013
• CVM Recall Initiation Date: 06/28/2013

Well Care Discount Pharmacy LLC, (dba Well Care Compounding Pharmacy), Las Vegas, NV

• 483 Issued 06/27/2018 (PDF - 467KB)
• Firm Press Release: Well Care Compounding Pharmacy Sterile Compounded Products: Recall - Lack Of Sterility Assurance (05/18/2016)
• 483 Issued 05/12/2016 (PDF - 1.6MB)
• CVM Recall Initiation Date: 05/17/2016

Wells Pharmacy Network LLC, Ocala, FL

• FMD-145 Letter Issued 06/08/2020 (PDF-165KB)
• 483 Issued 06/22/2018 (PDF - 203KB)
• 483 Issued 09/13/2016 (PDF - 812KB)
• Firm Press Release: Wells Pharmacy Network Issues Voluntary Nationwide Recall of Sterile Products due to Concern for Lack of Sterility Assurance (09/22/2016)
• 483 Issued 03/07/2014 (PDF - 1.2MB)
• 483 Issued 07/26/2013 (PDF - 1.1MB)
• CVM Recall Initiation Date: 09/21/2016

Wickliffe Pharmaceutical, Inc., Lexington, KY (see Wickliffe LLC)

• 483 Issued 04/07/2016 (PDF - 306KB)
• Warning Letter (08/14/2014)
• 483 Issued 05/22/2014 (PDF - 206KB)
• CVM Update: FDA Alerts Horse Owners and Veterinarians About Adverse Events Associated with Certain Unapproved Compounded Drugs in Horses (May 15, 2014)

Wickliffe LLC, Lexington, KY (formerly Wickliffe Pharmaceutical, Inc.)

• Untitled Letter Issued 06/10/2024 (PDF 478KB)
• 483 Issued 09/15/2023 (PDF- 220KB)
• Firm response to 483 dated 10/05/2023 (965KB)

Additional Resources

• Veterinary Adverse Drug Reaction, Lack of Effectiveness or Product Defect (PDF)
• Human Drug Compounding: Inspections, Recalls, and other Actions