PAPAVERINE HYDROCHLORIDE Injection, USP, 60 mg/2mL (30 mg/mL), packaged as a) 25 x 2mL Single Use Vials per box (NDC 72516-024-25) and b) 10 x 2mL Single Use Vials per box (NDC 72516-024-10); Manufactured for Oryza Pharmaceuticals, Inc.
Check against the official notice below — it lists the full affected range.
Vitae Enim Vitae Scientific, Inc. is recalling Papaverine Hydrochloride Injection, USP, 60 mg/2mL (30 mg/mL) distributed nationwide in the United States. The recall affects two package types: 2,098 boxes containing 25 single-use vials per box and 700 boxes containing 10 single-use vials per box. The affected lot numbers with expiration dates include 20VPHI037, 20VPHI038, and 20VPHI039 (expiring 12/31/2022); 21VPHI021, 21VPHI022, and 21VPHI023 (expiring 6/30/2023); and 21VPHI047 and 21VPHI048 (expiring 10/31/2023) for the 25-vial boxes, and lot 21VPHI023 (expiring 6/30/2023) for the 10-vial boxes.
The recall was initiated due to a lack of assurance of sterility resulting from deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of these products, which are intended to be sterile. The source record does not specify a remedy for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
Reason for recall: Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile. Distribution: Nationwide in the U.S.A Quantity: a) 2,098 boxes; b) 700 boxes Lot/code info: Lot #: a) 20VPHI037, 20VPHI038, 20VPHI039, Exp 12/31/2022; 21VPHI021, 21VPHI022, 21VPHI023, Exp 6/30/2023; 21VPHI047, 21VPHI048, Exp 10/31/2023; b) 21VPHI023, Exp 6/30/2023
Official record: FDA (Drug enforcement) ↗
Republished from the official source above; details can change — the source record controls.