FDA: Premier Pharmacy Labs recalls certain sterile injectable products

Editor's Note

The Food and Drug Administration (FDA) on April 12 announced the recall by Premier Pharmacy Labs (Weeki Wachee, Florida) of certain lots of sterile injectable products because of a potential lack of sterility assurance.

The products include morphine sulfate (2 mg/mL and 3 mg/mL), hydromorphone HCL 1 mg/mL, and neostigmine methylsulfate 1 mg/mL.

Microbial contamination was detected during routine testing of unreleased product lots because of interaction between the product syringe and tamper evident container closure, which may result in introduction of microorganisms into the products.

The company has not received any reports of adverse events related to this issue.