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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 numbera) 30-count bottles- Lot: 11MY2103 Exp. 11/30/22 Lot: 05JA2106 Exp. 6/30/22 b) 90-count bottles- Lot: 20MY2115 Exp. 11/30/22 Lot: 22JU2118 Exp. 12/31/22 Lot: 29JY2113 Exp. 12/31/22 Lot: 13SE2113 Exp. 2/28/23 Lot: 05JA2106 Exp. 6/30/22
Where it was soldAL, GA, FL, LA
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 byDirect_Rx
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: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 a) 30 Tabs
NDC72189-167-30
Show the full FDA record
Full product labelLosartan Pot./HCTZ 100/12.5 mg Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg For: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 a) 30 Tabs NDC 72189-167-30; b) 90 Tabs NDC 72189-167-90
Recalling firmDirect Rx
DistributionAL, GA, FL, LA
Quantity81 bottles
Recall initiated2022-05-05
Report date2022-06-08
Recall completed2023-10-05
Recall numberD-0971-2022
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.