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Class II · ModerateActive recall

LOSARTAN POTASSIUM and HYDROCHLOROTHIAZIDE TABLETS

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

Does this affect you?
Check your lot numberCount, lots, expiry: [90-count bottle] Lot BP02C008, exp 03/2019; [1000-count bottle] Lots BEF7D006, exp 03/2020
Where it was soldNationwide USA and Puerto Rico
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 an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

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 byTorrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana Inda
Distributed by / forTorrent Pharma Inc.
NDC13668-116-90
Show the full FDA record
Full product labelLOSARTAN POTASSIUM and HYDROCHLOROTHIAZIDE TABLETS, USP 50 mg/12.5 mg, a) 90-count bottle (NDC: 13668-116-90), b) 1000-count bottle (NDC: 13668-116-10), Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana Inda
Recalling firmTorrent Pharma Inc.
DistributionNationwide USA and Puerto Rico
Quantity18,780 bottles
Recall initiated2018-12-20
Report date2019-02-27
Recall completed—
Recall numberD-0505-2019
ClassificationClass II
FDA statusOngoing
Origin on fileKalamazoo MI 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.