FDAFDA · Food and drugs·Recall number D-0540-2023
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).
Published May 3, 2023 · Recall initiated: April 7, 2023
Status when published: Completed — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations; The impacted product and lot number was inadvertently placed into saleable inventory, which does not comply with approved procedures.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Methapharm Inc
- Distributor
- Nationwide in the USA
- Lot
- Lots: 220801; 220802; 220803 Exp. July 2024
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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