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Class II · ModerateRecall completed

Pantoprazole Sodium

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

Does this affect you?
Check your lot numberNo lot or expiration date is displayed on this carton.
Where it was soldIN
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

Correct Labeled Product Miscart/Mispack: some cartons labeled as Pantoprazole Sodium Delayed-Release may contain correctly labeled blister cards of Lorazepam tablets

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 byDr. Reddy's Laboratories Limited, India and Distributed by Major Pharmaceuticals, Livonia, MI --- foreign manufacturer
Distributed by / forMajor Pharmaceuticals, Livonia, MI ---
NDC0904-6235-61
Show the full FDA record
Full product labelPantoprazole Sodium, Delayed-release tablets, USP, 40 mg tablets, 100 (10x10) unit dose packages, Manufactured by Dr. Reddy's Laboratories Limited, India and Distributed by Major Pharmaceuticals, Livonia, MI --- NDC 0904-6235-61
Recalling firmLegacy Pharmaceutical Packaging
DistributionIN
Quantityunknown
Recall initiated2014-04-09
Report date2014-06-18
Recall completed2017-01-06
Recall numberD-1363-2014
ClassificationClass II
FDA statusTerminated
Origin on fileEarth City MO United States

Related

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.