Sterile injectable products by Premier Pharmacy Labs: Recall—Lack of sterility assurance

FDA Apr 16, 2018

Issue

Premier Pharmacy Labs is voluntarily recalling injectable products due to a potential lack of sterility assurance. 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 micro-organisms into the products.

Administration of nonsterile 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.

Background

The product can be identified by the product description and beyond use date (BUD) on the individual product or shipping bag. Product lots were distributed nationwide to hospital pharmacy, clinic, and health-care facilities.

Recommendation

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 health-care facilities that have product that are 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 a.m. and 5:00 p.m. Eastern Time, Monday through Friday or sending an email to recalls@premierpharmacylabs.com. Consumers should contact their physician or health-care provider if they have experienced any problems that may be related to taking or using this drug product.

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