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.
Check against the official notice below — it lists the full affected range.
Vitae Enim Vitae Scientific, Inc. is recalling Phenobarbital Sodium Injection, USP, 65mg/mL, distributed nationwide in the United States. The recall affects two package sizes: 21,501 boxes containing 25 vials per box (NDC 42494-415-25) and 4,846 boxes containing 3 vials per box (NDC 42494-415-03). Multiple lot numbers are included in this recall, with expiration dates ranging from March 31, 2022 through August 31, 2024.
The recall was initiated due to deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility assurance of these products, which are intended to be sterile for injection use. The recall source does not specify a remedy or next steps 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) 21,501 boxes; b) 4,846 boxes Lot/code info: Lot #: a) 20VPSI007, Exp 3/31/2022; 20VPSI015, Exp 5/30/2022; 20VPSI018, Exp 6/1/2022; 20VPSI032, Exp 11/30/2022; 21VPSI002, 21VPSI003, Exp 1/31/2023; 21VPSI006, Exp 3/31/2023; 21VPSI012, 21VPSI020, Exp 5/31/2023; 21VPSI035, Exp 7/31/2023; 21VPSI037, 21VPSI038, Exp 8/31/2023; 21VPSI043, 21VPSI044, Exp 10/31/2023; 21VPSI050, 21VPSI051, Exp 11/30/2023; 22VPSI004, Exp 7/31/2024; 22VPSI006, Exp 8/31/2024; b) 20VPSI008, Exp 3/31/2022; 20VPSI019, Exp 6/30/2022; 21VPSI050, Exp 11/30/2023,
Official record: FDA (Drug enforcement) ↗
Republished from the official source above; details can change — the source record controls.