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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: [30-count bottle] Lot BEF6D054, exp 8/31/2020; [90-count bottle] Lot BP04C092, exp 10/31/2019; Lots BP04D012, BP04D013, exp 12/31/2019; Lots BEF6D012, BEF6D013, exp 3/31/2020; Lots BEF6D060, BEF6D061, BEF6D063, exp 9/30/2020; Lots BEF6D076, BEF6D077, BEF6D078, BEF6D079, exp 10/31/2020; Lots BEF6D100, BEF6D101, BEF6D102, exp 11/30/2020; Lots BEF6E001, BEF6E002, BEF6E003, BEF6E004, BEF6E008, BEF6E009, BEF6E010, BEF6E011, BEF6E012, exp 12/31/2020
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 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 byTorrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India foreign manufacturer
Distributed by / forTorrent Pharma Inc.
NDC13668-118-30
Show the full FDA record
Full product labelLosartan Potassium and Hydrochlorothiazide Tablets, USP, 100mg/25mg, a) 30-count (NDC: 13668-118-30) b) 90-count (NDC: 13668-118-90), c) 1000-count (NDC: 13668-118-10), per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India
Recalling firmTorrent Pharma Inc.
DistributionNationwide USA and Puerto Rico
Quantity239,016 bottles
Recall initiated2019-04-18
Report date2019-05-08
Recall completed—
Recall numberD-1269-2019
ClassificationClass II
FDA statusOngoing
Origin on fileBasking Ridge NJ 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.