FDA Recall: Premier Pharmacy Labs

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

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 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 sterile drug products that were distributed to the consumer level.

Premier Pharmacy Labs is notifying customers of the voluntary recall by certified letter. Customers who have any of the affected medications that are being recalled should immediately quarantine the product and discontinue use. For more information on the specific lot numbers affected, please visit: https://premierpharmacylabs.com/urgent-product-recall/

You may contact Premier Pharmacy Labs Monday through Friday, between 8:30 a.m. and 5:00 p.m., ET at 800-868-4978 or via e-mail at recalls@premierpharmacylabs.com to arrange return and credit.

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 U.S. Mail, or by fax.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. If you have additional questions, please contact Jillian Winans, regulatory affairs specialist, at jwinans@ascrs.org or 703-591-2220.