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Class II · ModerateRecall completed

Losartan Potassium And Hydrochlorothiazide

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

Does this affect you?
Check your lot numberLot: 25OC2116 Exp. 5/31/23
Where it was soldFL
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 byDirectRx
Brand nameLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
Generic nameLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
Active ingredient(s)HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM
Distributed by / forDirect Rx Dawsonville, GA 30534 Mfg. For Macleods Pharma USA, Inc. Plainsboro, NJ 08540
NDC72189-290-90
Show the full FDA record
Full product labelLosartan Pot/HCTZ 100/12.5 mg 90 Tabs NDC 72189-290-90 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg. For Macleods Pharma USA, Inc. Plainsboro, NJ 08540
Recalling firmDirect Rx
DistributionFL
Quantity11 bottles
Recall initiated2022-05-11
Report date2022-06-01
Recall completed2022-12-02
Recall numberD-0893-2022
ClassificationClass II
FDA statusTerminated
Origin on fileDawsonville GA United States

Related

Losartan recallsHydrochlorothiazide 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.