Reported May 8, 2019 · Ongoing
Losartan Potassium Tablets, USP, 50 mg, a) 90-count (NDC: 13668-409-90), b)1000-count (NDC: 13668-409-10) per bottle,…
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 Tablets, USP, 50 mg
- a) 90-count (NDC13668-409-90)
- b)1000-count (NDC13668-409-10) 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 [90-count bottle] Lots 4DU2D005, 4DU2D006, exp 12/31/2019 2 Lots 4DU2D026, 4DU2D027, 4DU2D029, exp 3/31/2020 3 Lot 4DU2E007, exp 12/31/2020 4 [1000-count bottle] Lot 4DU2D017, exp 2/29/2020, Lots 4DU2D025, 4DU2D028, exp 3/31/2020 5 Lots 4DU2D040, 4DU2D041, 4DU2D042, 4DU2D045, 4DU2D046, 4DU2D047, 4DU2D048, exp 8/31/2020 6 Lot BDK2E001, exp 12/31/2020 7 Lots 4DU2E042, 4DU2E044, exp 2/28/2021 8 Lots BDK2E012, BDK2E013, exp 8/31/2021 - Amount recalled
- 164,424 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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