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Class II · ModerateRecall completed

Pantoprazole sodium for Injection 40 mg*/vial

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLots: 220801; 220802; 220803 Exp. July 2024
Where it was soldNationwide in the USA
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

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

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Distributed by / forMethapharm Inc
NDC67850-150-10
Show the full FDA record
Full product labelPantoprazole 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).
Recalling firmMethapharm Inc
DistributionNationwide in the USA
Quantity5377 cartons
Recall initiated2023-04-07
Report date2023-05-03
Recall completed—
Recall numberD-0540-2023
ClassificationClass II
FDA statusCompleted
Origin on fileCoral Springs FL United States

Related

Pantoprazole recallsRecent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.