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).
Reported: May 3, 2023 Initiated: April 7, 2023 #D-0540-2023
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.
Details
- Recalling Firm
- Methapharm Inc
- Units Affected
- 5377 cartons
- Distribution
- Nationwide in the USA
- Location
- Coral Springs, FL
Frequently Asked Questions
What product was recalled? ▼
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).. Recalled by Methapharm Inc. Units affected: 5377 cartons.
Why was this product recalled? ▼
CGMP Deviations; The impacted product and lot number was inadvertently placed into saleable inventory, which does not comply with approved procedures.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 3, 2023. Severity: Moderate. Recall number: D-0540-2023.
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