Vitae Enim Vitae Scientific, Inc. recalls PAPAVERINE HYDROCHLORIDE Injection, USP, 60 mg/2mL (30 mg/mL), packaged as a) 25 x 2mL Single Use Vials per box (NDC 725
Recalled April 13, 2022 · FDA recall D-0742-2022 · Vitae Enim Vitae Scientific
Hazard
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile. · FDA Class II
Units
a) 2,098 boxes; b) 700 boxes
Sold at
Nationwide in the U.S.A
Description
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
Product
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.
Manufacturer(s)
Vitae Enim Vitae Scientific, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →