Premier Pharmacy Labs Issues Voluntary Nationwide Recall of Specific Sterile Injectable Products Lots Due to a Potential Lack of Sterility Assurance
- Company Announcement Date:
- April 11, 2018
- FDA Publish Date:
- April 11, 2018
- Product Type:
- Reason for Announcement:
- Company Name:
- Premier Pharmacy Labs
- Brand Name:
Brand Name(s)Premier Pharmacy Labs
- Product Description:
Product DescriptionSterile Injectable Drug Products
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/
|Morphine Sulfate (Single Dose Syringe) 4mg/mL Preservative Free Injection||69623-127-10||Rigid plastic syringe, 3mL||pain reliever/
|Hydromorphone HCL (Single Dose Syringe) 1mg/mL Preservative Free Injection||69623-249-10||Rigid plastic syringe, 3mL||pain reliever/
|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 email@example.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: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm 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
- Ron Martin, Director of Quality
- Vern Allen, CEO