Reported Apr 17, 2019 · Ongoing
Losartan Potassium / Hydrochlorothiazide Tablets, USP 50mg/12.5mg, a) 30-count (NDC: 13668-116-30), 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 / 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
- ForTorrent Pharma, Inc, 150 Allen Road, Suite 102, Basking Ridge, NJ
- Lot codes and dates
8 of 8 products
Products covered by this recall # Product as published 1 [30-count bottle] Lot BEF7D017,exp 6/30/2020 [90-count bottle] Lots BEF7D010, BEF7D011, exp 4/30/2020 2 Lot BEF7D018, exp 6/30/2020 3 Lot BEF7D009, exp 4/30/2020 4 Lots 4P02E002, 4P02E003, 4P02E004, exp 1/31/2021 5 [1000-count bottle] Lots BEF7D008, BEF7D012, BEF7D013, exp 4/30/2020 6 Lot BEF7D022, exp 8/31/2020 7 Lot BEF7D049, exp 11/30/2020 8 Lots 4P02E005, 4P02E006, exp 1/31/2021 - Amount recalled
- N/A
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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