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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 # BLH2002A, exp. date 11/2022 BLH2003B, exp. date 11/2022 BLH2004A, exp. date 11/2022
Where it was soldProduct was distributed nationwide.
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- AZIDO Impurity levels observed to be above acceptable limits

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 byMacleods Pharmaceuticals Limited
Brand nameLOSARTAN POTASSIUM
Generic nameLOSARTAN POTASSIUM
Active ingredient(s)LOSARTAN POTASSIUM
Distributed by / forMacleods Pharma Usa Inc
NDC33342-044-10
Show the full FDA record
Full product labelLosartan Potassium Tablets, USP, 25 mg, a) 90-count bottles (NDC # 33342-044-10), b) 1000-count bottles (NDC # 33342-044-44), Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536
Recalling firmMacleods Pharma Usa Inc
DistributionProduct was distributed nationwide.
Quantity12,408/90 count bottles; 1670/1000 count bottles =2,786,720 tablets
Recall initiated2022-04-15
Report date2022-05-11
Recall completed2023-10-13
Recall numberD-0832-2022
ClassificationClass II
FDA statusTerminated
Origin on filePlainsboro NJ United States

Related

Losartan recallsRecent drug recallsCheck another medication

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.