Vitae Enim Vitae Scientific, Inc. recalls PHENOBARBITAL Sodium Injection, USP, 65mg/mL, packaged as a) 25 x 1 mL Vials per box (NDC 42494-415-25) and b) 3 x 1 mL
Recalled April 13, 2022 · FDA recall D-0743-2022 · 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) 21,501 boxes; b) 4,846 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
PHENOBARBITAL Sodium Injection, USP, 65mg/mL, packaged as a) 25 x 1 mL Vials per box (NDC 42494-415-25) and b) 3 x 1 mL Vials per box (NDC 42494-415-03), Rx only, Manufactured for Cameron Pharmaceuticals, LLC.
Manufacturer(s)
Vitae Enim Vitae Scientific, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →