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Class II · ModerateActive recall

LOSARTAN POTASSIUM TABLETS

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

Does this affect you?
Check your lot numberLots 1195625A, 1195624A, 1195623A, exp. date 03/2020
Where it was soldBulk product was distributed to one re-packager in California.
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

Made byArrow Pharma (Malta) Ltd., Birzebbugia, Malta
Distributed by / forTeva Pharmaceuticals USA
NDC0591-3746-00
Show the full FDA record
Full product labelLOSARTAN POTASSIUM TABLETS, USP 50 mg, Bulk, Rx only, For Further Manufacturing, Packing or Repackaging only, Manufactured by: Arrow Pharma (Malta) Ltd., Birzebbugia, Malta NDC 0591-3746-00
Recalling firmTeva Pharmaceuticals USA
DistributionBulk product was distributed to one re-packager in California.
QuantityN/A
Recall initiated2020-03-25
Report date2020-04-15
Recall completed—
Recall numberD-1101-2020
ClassificationClass II
FDA statusOngoing
Origin on fileParsippany NJ 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.