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Class II · ModerateActive recall

Losartan Potassium Tablets USP 50 mg 50 tablets (5x10) Unit Dose

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

Does this affect you?
Check your lot numberLot: 20121 Exp. 6/30/2019
Where it was soldNationwide
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: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 0.96 parts per million.

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 / forAvKARE Inc. Pulaski, TN 38478
NDC50268-517-15
Show the full FDA record
Full product labelLosartan Potassium Tablets USP 50 mg 50 tablets (5x10) Unit Dose Rx Only NDC 50268-517-15 Manufactured for: AvKARE Inc. Pulaski, TN 38478
Recalling firmAVKARE Inc.
DistributionNationwide
Quantity1438 cartons (71,900 tablets)
Recall initiated2019-04-24
Report date2019-05-08
Recall completed—
Recall numberD-1249-2019
ClassificationClass II
FDA statusOngoing
Origin on filePulaski TN 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.