FDA Recall: Premier Pharmacy Labs Issues Voluntary Recall of Injectable Products Due to Lack of Sterility Assurance 

Premier Pharmacy Labs is voluntarily recalling injectable products, including neostigmine methylsulfate, 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 microorganisms into the products. Review the full press release for a list of affected products and lot numbers.

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 that 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 800-752-7139 between the hours of 8:30 a.m. through 5:00 p.m. ET, Monday through Friday, or sending an email to recalls@premierpharmacylabs.com.

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.