July 05, 2019
Premier Pharmacy Labs Inc. is recalling all unexpired droperidol injectable sterile solution, 0.625 mg/mL, 1 mL in 3-mL sterile single-use syringes (NDC 69623-185-10), according to the July 3, 2019, US Food and Drug Administration (FDA) Enforcement Report.
“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 FDA wrote in the report.
The recall affects 2315 syringes of droperidol distributed throughout the United States.
“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.”
The company initiated the voluntary recall on June 18, 2019. That same week, the FDA designated the recall Class II, signaling use of the recalled syringes could cause temporary or medically reversible adverse health consequences. A remote possibility of serious harm also exists.
Droperidol is a prescription sedative, tranquilizer, and anti-nausea injection used before surgery or medical procedures.