Methapharm Inc: Drug Recall
Recall #D-0540-2023 · 04/07/2023
Class II: Risk
Recall Details
- Recall Number
- D-0540-2023
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- Methapharm Inc
- Status
- Completed
- Date Initiated
- 04/07/2023
- Location
- Coral Springs, FL, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5377 cartons
Reason for Recall
CGMP Deviations; The impacted product and lot number was inadvertently placed into saleable inventory, which does not comply with approved procedures.
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).
Distribution Pattern
Nationwide in the USA
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.