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Class II · ModerateRecall completed

Omeprazole

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

Does this affect you?
Check your lot numberLot Number 59627; Expiration Date 02/2014
Where it was soldKY & TN
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

Failed Tablet/Capsule Specification: some capsules over time do not meet or are suspected to not meet the specification for acid resistance.

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 byLannett Company, Inc.
Brand nameOMEPRAZOLE
Generic nameOMEPRAZOLE
Active ingredient(s)OMEPRAZOLE
Distributed by / forKremers Urban Pharmaceuticals Inc. Princeton, NJ 08540, USA
NDC62175-118-43
Show the full FDA record
Full product labelOmeprazole Delayed-Release Capsules, USP, 20 mg, Rx Only, 1000 Capsules per bottle, Distributed by: Kremers Urban Pharmaceuticals Inc. Princeton, NJ 08540, USA, NDC: 62175-118-43
Recalling firmKremers Urban Pharmaceuticals, Inc.
DistributionKY & TN
Quantity3867 bottles
Recall initiated2013-09-16
Report date2013-11-27
Recall completed2014-05-09
Recall numberD-009-2014
ClassificationClass II
FDA statusTerminated
Origin on fileSeymour IN United States

Related

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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.