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  4. Premier Pharmacy Labs Issues Voluntary Nationwide Recall of Specific Sterile Injectable Products Lots Due to a Potential Lack of Sterility Assurance
  1. Recalls, Market Withdrawals, & Safety Alerts

COMPANY ANNOUNCEMENT

Premier Pharmacy Labs Issues Voluntary Nationwide Recall of Specific Sterile Injectable Products Lots Due to a Potential Lack of Sterility Assurance

This recall has been completed and FDA has terminated this recall.

When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.

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Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Drugs
Reason for Announcement:
Recall Reason Description
Due to a Potential Lack of Sterility Assurance
Company Name:
Premier Pharmacy Labs
Brand Name:
Brand Name(s)
Premier Pharmacy Labs
Product Description:
Product Description
Sterile Injectable Drug Products

Company Announcement

Premier Pharmacy Labs is voluntarily recalling the following products due to a potential lack of sterility assurance:

Product Name/Description Product NDC Number Type of Packaging Indication Premier Pharmacy Labs Lot Number Beyond Use Dates Quantity Shipped Date(s) Distributed
Morphine Sulfate (Single Dose Syringe) 2mg/mL Preservative Free Injection 69623-129-10 Rigid plastic syringe, 3mL pain reliever/
reducer		 MOR030518IJDSA
MOR030518IJDSB
MOR030518IJDSC
MOR030518IJDSD
MOR030518IJDSE		 06/03/2018
06/03/2018
06/03/2018
06/03/2018
06/03/2018		 925
904
928
930
868		 03/23/2018
03/23/2018
03/23/2018
03/23/2018
03/28/2018
Morphine Sulfate (Single Dose Syringe) 4mg/mL Preservative Free Injection 69623-127-10 Rigid plastic syringe, 3mL pain reliever/
reducer		 MOR022318NWDSA
MOR022318NWDSB
MOR022318NWDSC
MOR022318NWDSD
MOR022318NWDSE		 05/24/2018
05/24/2018
05/24/2018
05/24/2018
05/24/2018		 540
925
920
902
905		 03/06/2018
03/06/2018
03/06/2018
03/16/2018
03/16/2018
Hydromorphone HCL (Single Dose Syringe) 1mg/mL Preservative Free Injection 69623-249-10 Rigid plastic syringe, 3mL pain reliever/
reducer		 HYD030118IJDSA
HYD030118IJDSB
HYD030118IJDSD
HYD030118IJDSE		 05/30/2018
05/30/2018
05/30/2018
05/30/2018		 921
870
928
851		 03/22/2018
03/22/2018
03/22/2018
03/22/2018
Neostigmine Methylsulfate (Single Dose Syringe) 1mg/mL Injection 69623-234-14 Rigid plastic syringe, 3mL to reverse some of the nerve and muscle blocking agents used in surgery. NEO022218SVDS 08/21/2018 600 03/19/2018

Microbial contamination was detected during routine testing of subsequent unreleased product lots due to interaction between the product syringe and tamper evident container closure, which may result in the potential introduction of microorganisms into the products.

Administration of non-sterile injection products that are intended to be sterile may result in a site-specific or systemic infection, which in turn may cause hospitalization, significant morbidity (permanent organ damage), or a fatal outcome. To date, Premier Pharmacy Labs has not received any reports of adverse events related to this issue, but understanding the potential risk, is voluntarily initiating this product recall.

The product can be identified by the product description in the above table and beyond use date (BUD) on the individual product or shipping bag. The listed product lots were distributed Nationwide to hospital pharmacy, clinic, and healthcare facilities.

Premier Pharmacy Labs is notifying its distributors and customers by certified letter and is arranging for return/replacement of all recalled products. Hospital pharmacy, clinic, and healthcare facilities that have product which is being recalled should stop using and return to Premier Pharmacy Labs per the official recall notification/customer reply form included in the certified letter sent to all affected clients.

Consumers with questions regarding this recall can contact Premier Pharmacy Labs by calling 1-800-752-7139 between the hours of 8:30 am and 5:00 pm Eastern Time, Monday through Friday or sending an email to recalls@premierpharmacylabs.com. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

  • Complete and submit the report Online
  • Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Company Contact Information

Consumers:
Ron Martin, Director of Quality
1-800-752-7139
Media:
Vern Allen, CEO
1-800-752-7139
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