Drug product
Pantoprazole sodium for Injection 40 mg*/vial, Single-dose Vial, Rx only, For Intravenous Infusion Only, Mfd. for Methapharm, Inc. Coral Springs, FL, 33065, NDC 67850-150-10 (carton), NDC 67850-150-00 (vial).
D-0540-2023
Product summary
- Firm
- Methapharm Inc
- Event
- Event 92113
- Status
- Completed
- Classification
- Class II
- Quantity
- 5377 cartons
- Official record key
drug-enforcement:D-0540-2023
Official wording
Reason: CGMP Deviations; The impacted product and lot number was inadvertently placed into saleable inventory, which does not comply with approved procedures.
Code information: Lots: 220801; 220802; 220803 Exp. July 2024
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations