Drug recall D-0744-2022
Product
PHENOBARBITAL Sodium Injection, USP, 130 mg/mL, packaged as a) 25 x 1 mL Vials per box (NDC 42494-416-25) and b) 3 x 1mL Vials per box (NDC 42494-416-03), 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) 20VPSI011, Exp. 4/30/2022; 20VPSI014, Exp. 5/31/2022; 20VPSI020, 20VPSI022, 20VPSI023, Exp. 7/31/2022; 21VPSI007, Exp. 3/31/2023; 21VPSI013, Exp. 5/31/2023; 21VPSI027, Exp. 6/30/2023; 21VPSI039, Exp. 8/31/2023; 21VPSI042, Exp. 10/31/2023; 21VPSI049, Exp. 11/30/2023; 21VPSI052, Exp. 12/31/2023; 22VPSI005, Exp. 7/31/2024; 22VPSI007, Exp. 8/31/2024; Lots: b) 22VPSI007, Exp. 8/31/2024; 20VPSI009, Exp. 3/31/2022; 20VPSI020, Exp. 7/31/2022; 21VPSI039, Exp. 8/31/2023; 22VPSI005, Exp. 7/31/2024.
Recall details
- Recalling firm
- Vitae Enim Vitae Scientific, Inc., San Diego, CA
- Quantity
- a) 18,531 boxes; b) 4,492 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