Reported May 3, 2023 · Completed

Pantoprazole sodium for Injection 40 mg*/vial, Single-dose Vial, Rx only, For Intravenous Infusion Only, Mfd. for…

Methapharm Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Methapharm Inc · 11772 W Sample Rd Ste 101 · Coral Springs, FL · 33065-3166

Is this the product you have?

  • 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).
Lot codes and dates
  • Lots
    • 220801
    • 220802
    • 220803 Exp. July 2024
Amount recalled
5377 cartons

Where it was sold

  • Nationwide

Why it was recalled

CGMP Deviations; The impacted product and lot number was inadvertently placed into saleable inventory, which does not comply with approved procedures.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Data as of Sep 19, 8:02 PM UTC

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