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Class II · ModerateActive recall

Pantoprazole Sodium

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

Does this affect you?
Check your lot numberLot #: PAN22542, Exp. Date: 9/2024
Where it was soldNationwide within the United States
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: Discoloration

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

Made byCamber Pharmaceuticals, Inc.
Brand namePANTOPRAZOLE SODIUM
Generic namePANTOPRAZOLE
Active ingredient(s)PANTOPRAZOLE SODIUM
Distributed by / forCamber Pharmaceuticals Inc., Piscataway, NJ, 08854, By: Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahabubnagar- 509 301, India
NDC31722-713-10
Show the full FDA record
Full product labelPantoprazole Sodium Delayed Release Tablets USP 40mg, 1000-count bottles, Rx only, Manufactured for: Camber Pharmaceuticals Inc., Piscataway, NJ, 08854, By: Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahabubnagar- 509 301, India NDC 31722-713-10
Recalling firmHetero USA Inc
DistributionNationwide within the United States
Quantity2,352 bottles
Recall initiated2023-03-14
Report date2023-04-19
Recall completed—
Recall numberD-0530-2023
ClassificationClass II
FDA statusOngoing
Origin on filePiscataway NJ 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.