July 05, 2019
Premier Pharmacy Labs Inc. is recalling all unexpired phenylephrine hydrochloride in 0.9% sodium chloride, 1000 mcg/10 mL (100 mcg/mL), 10-mL single-dose syringes (NDC 69623-236-16) due to a lack of sterility assurance.
According to the July 3, 2019, US Food and Drug Administration (FDA) Enforcement Report, an “FDA inspection found insufficient environmental controls, potential cross-contamination, and lack of product-specific process validations that can result in a lack of sterility assurance.”
The recall affects 1040 syringes of phenylephrine hydrochloride distributed throughout the United States.
Premier Pharmacy Labs voluntarily initiated the recall June 18, 2019. The FDA designated the recall Class II within the week. Drugs affected by Class II recalls may cause temporary or medically reversible adverse health consequences if used. While remote, a possibility of serious harm also exists.
“Administration of a drug product intended to be sterile that is not sterile could result in serious infections that may be life-threatening,” Premier Pharmacy Labs wrote in a June 18, 2019, announcement. “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.”
Phenylephrine hydrochloride is a prescription injection used to treat hypotension caused by vasodilation during anesthesia.