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Class II · ModerateRecall completed

Losartan Potassium

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

Does this affect you?
Check your lot numberLot #: GS017479, Expiration 01/2020
Where it was soldUS Nationwide One (1) US government account. No foreign accounts.
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: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.

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 / forGolden State Medical Supply Inc.
NDC60429-317-30
Show the full FDA record
Full product labelLosartan Potassium, 50 mg tablets, 30 count bottle, NDC 60429-317-30
Recalling firmGolden State Medical Supply Inc.
DistributionUS Nationwide One (1) US government account. No foreign accounts.
Quantity4,037 bottles (121,110 tablets)
Recall initiated2019-06-14
Report date2019-07-17
Recall completed2020-02-19
Recall numberD-1462-2019
ClassificationClass II
FDA statusTerminated
Origin on fileCamarillo CA 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.