D-0540-2023 Class II
Recall Details
- Product Type
- Drugs
- Report Date
- May 3, 2023
- Initiation Date
- April 7, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5377 cartons
Product Description
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).
Reason for Recall
CGMP Deviations; The impacted product and lot number was inadvertently placed into saleable inventory, which does not comply with approved procedures.
Distribution Pattern
Nationwide in the USA
Code Information
Lots: 220801; 220802; 220803 Exp. July 2024