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Class II · ModerateRecall completed

Losartan Potassium Tablets USP 50 mg

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

Does this affect you?
Check your lot numbera) CL018008A, exp Mar 2020; b) CL018008B, exp Mar 2020; c) CL018009A, exp Mar 2020
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

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 byVivimed Life Sciences Private Limited, Tamil Nadu, India, Manufactured for: Heritage Pharmaceutical Inc., East Brunswick, NJ 08816 foreign manufacturer
Distributed by / forHeritage Pharmaceutical Inc., East Brunswick, NJ 08816
NDC23155-645-03
Show the full FDA record
Full product labelLosartan Potassium Tablets USP 50 mg, a) 30 count (NDC 23155-645-03), b) 90 count (NDC 23155-645-09) and c) 1000 count (NDC 23155-645-10) bottles, Rx only, Manufactured by: Vivimed Life Sciences Private Limited, Tamil Nadu, India, Manufactured for: Heritage Pharmaceutical Inc., East Brunswick, NJ 08816 NDC 23155-645-09
Recalling firmAvet Pharmaceuticals, Inc.
DistributionNationwide
Quantitya) 2,904; b) 14,316; c) 1,368 bottles
Recall initiated2020-03-26
Report date2020-04-15
Recall completed2021-03-08
Recall numberD-1103-2020
ClassificationClass II
FDA statusTerminated
Origin on fileEast Brunswick 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.