FlaggedRx← Medication recall checkHome
Class II · ModerateRecall completed

Losartan Potassium 100 mg

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

Does this affect you?
Check your lot numberLot: 27AU1801 Exp. 02/28/2021
Where it was soldGA
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 per manufacturer

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 / forDirect Rx Dawsonville, GA 30534
NDC61919-952-30
Show the full FDA record
Full product labelLosartan Potassium 100 mg, 30 Tabs bottles, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 NDC 61919-952-30
Recalling firmDirect Rx
DistributionGA
Quantity33 bottles
Recall initiated2019-04-30
Report date2020-10-14
Recall completed2020-12-04
Recall numberD-0018-2021
ClassificationClass II
FDA statusTerminated
Origin on fileDawsonville GA 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.