Reported May 8, 2019 · Ongoing
Losartan Potassium and Hydrochlorothiazide Tablets, USP, 50mg/12.5mg, a) 30-count (NDC: 13668-116-30), b) 90-count…
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, 50mg/12.5mg
- a) 30-count (NDC13668-116-30)
- b) 90-count (NDC13668-116-90)
- c) 1000-count (NDC13668-116-10), per bottle, Rx only
- Manufactured byTorrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India
- Lot codes and dates
15 of 15 products
Products covered by this recall # Product as published 1 [30-count bottle] Lot BP02C051, exp 10/31/2019 2 Lot BP02D005, exp 12/31/2019 3 Lot BEF7D047, exp 11/30/2020 4 [90-count bottle] Lot BP02C050, exp 10/31/2019 5 Lots BP02D006, BP02D007, exp 12/31/2019 6 Lot BP02D012, exp 1/31/2020 7 Lot BEF7D003, exp 3/31/2020 8 Lots BEF7D026, BEF7D027, BEF7D028, exp 8/31/2020 9 Lots BEF7D045, BEF7D046, exp 11/30/2020 10 Lot BEF7E005, exp 1/31/2021 11 [1000-count bottle] Lots BP02C051, BP02C052, exp 10/31/2019 12 Lot BEF7D005, exp 3/31/2020 13 Lots BEF7D029, BEF7D030, exp 8/31/2020 14 Lot BEF7D048, exp 11/30/2020 15 Lots BEF7E001, BEF7E002, BEF7E003, BEF7E004, exp 12/31/2020 - Amount recalled
- 331,764 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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