Drug recall D-0743-2022
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.
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.
Lots and codes
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,
Recall details
- Recalling firm
- Vitae Enim Vitae Scientific, Inc., San Diego, CA
- Quantity
- a) 21,501 boxes; b) 4,846 boxes
- Distribution
- Nationwide in the U.S.A
- Type
- Voluntary: Firm initiated
- Recall initiated
- March 14, 2022
- Terminated
- August 15, 2024
Related products
- Phenobarbital Sodium – drug information
- NDC 42494-415 Phenobarbital Sodium · Phenobarbital Sodium 65 mg/mL · Cameron Pharmaceuticals
- NDC 42494-416 Phenobarbital Sodium · Phenobarbital Sodium 130 mg/mL · Cameron Pharmaceuticals