Reported May 8, 2019 · Ongoing
Losartan Potassium and Hydrochlorothiazide Tablets, USP, 100mg/25mg, a) 30-count (NDC: 13668-118-30) b) 90-count (NDC:…
Torrent Pharma Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Torrent Pharma Inc. · 150 Allen Rd Ste 102 · Basking Ridge, NJ · 07920-3856
Is this the product you have?
- Losartan Potassium and Hydrochlorothiazide Tablets, USP, 100mg/25mg
- a) 30-count (NDC13668-118-30)
- b) 90-count (NDC13668-118-90)
- c) 1000-count (NDC13668-118-10), per bottle, Rx only
- Manufactured byTorrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India
- Lot codes and dates
8 of 8 products
Products covered by this recall # Product as published 1 [30-count bottle] Lot BEF6D054, exp 8/31/2020 2 [90-count bottle] Lot BP04C092, exp 10/31/2019 3 Lots BP04D012, BP04D013, exp 12/31/2019 4 Lots BEF6D012, BEF6D013, exp 3/31/2020 5 Lots BEF6D060, BEF6D061, BEF6D063, exp 9/30/2020 6 Lots BEF6D076, BEF6D077, BEF6D078, BEF6D079, exp 10/31/2020 7 Lots BEF6D100, BEF6D101, BEF6D102, exp 11/30/2020 8 Lots BEF6E001, BEF6E002, BEF6E003, BEF6E004, BEF6E008, BEF6E009, BEF6E010, BEF6E011, BEF6E012, exp 12/31/2020 - Amount recalled
- 239,016 bottles
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
- Nationwide
- PR
Why it was recalled
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.
This product could cause temporary or reversible health problems — stop using it.
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