Premier Pharmacy Labs Issues Voluntary Nationwide Recall of all Unexpired Sterile Drug Product Lots Due to Lack of Sterility Assurance

Summary

Company Announcement Date:: June 18, 2019
FDA Publish Date:: June 18, 2019
Product Type:: Animal & Veterinary
Drugs
Reason for Announcement:: Lack of Sterility Assurance
Company Name:: Premier Pharmacy Labs Inc
Brand Name:: Premier Pharmacy Labs
Product Description:: All Products Intended to be Sterile

Company Announcement

Premier Pharmacy Labs is voluntarily recalling all unexpired products, intended to be sterile, due to a lack of sterility assurance. The Unexpired Sterile Drug Product Lots (include dates dispensed) are being recalled due to concerns presented during the latest FDA inspection including insufficient environmental controls, potential cross contamination and lack of product specific process validations. The nationwide recall includes lots of sterile drug products to the consumer/user level.

Administration of a drug product intended to be sterile that is not sterile could result in serious infections that may be life-threatening. To date, Premier Pharmacy Labs has not received any reports of adverse events related to the products but is issuing this recall out of an abundance of caution following a commitment made during a recent inspection of the company’s facility.

The scope of this recall is all commercially distributed product lots compounded in the Weeki Wachee, FL location currently within their labeled expiration date in response to an FDA concerns raised during the most recent inspection carried out from 29 April, 2019 to 12 June, 2019.

Premier Pharmacy Labs is notifying customers of the voluntary recall by certified letter. Customers that have any of the affected medications that are being recalled should immediately quarantine the product, discontinue use and destroy per the hospital protocol. Customers with any of the affected medications can also reference Premier Pharmacy Labs Website at https://premierpharmacylabs.com/ for more information on the specific lot numbers affected and contact information.

Patients and healthcare providers with questions regarding this recall can contact Premier Pharmacy Labs at 1-800-752-7139, Monday through Friday, between 8:30am and 5pm, Central Standard Time or via e-mail at recalls@premierpharmacylabs.com.

Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to the use of these products.

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.