Reported Apr 17, 2019 · Ongoing
LOSARTAN POTASSIUM TABLETS, USP, 50 mg, a) 30-count (NDC: 13668-409-30), b) 90-count (NDC: 13668-409-90), c) 1000-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 TABLETS, USP, 50 mg
- a) 30-count (NDC13668-409-30)
- b) 90-count (NDC13668-409-90)
- c) 1000-count (NDC13668-409-10), 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
9 of 9 products
Products covered by this recall # Product as published 1 [30-count bottle] Lot 4DU2D077, exp 10/31/2020 2 [90-count bottle] Lot 4DU2D087, exp 10/31/2020 3 Lots 4DU2E023, 4DU2E024, 4DU2E026, 4DU2E027, 4DU2E028, 4DU2E029, 4DU2E020, exp 1/31/2021 4 Lots 4O50E007, 4O50E008, exp 8/31/2021 5 [1000 count bottle] Lots 4DU2D067, 4DU2D069, 4DU2D063, 4DU2D064, 4DU2D065, 4DU2D066, exp 9/30/2020 6 Lots 4DU2D084, 4DU2D085, 4DU2D083, 4DU2D082, 4DU2D072, 4DU2D077, 4DU2D078, 4DU2D079, 4DU2D081, 4DU2D080, 4DU2D070, 4DU2D073, 4DU2D074, 4DU2D075, 4DU2D086, 4DU2D088, 4DU2D089, exp 10/31/2020 7 Lots 4DU2E019, 4DU2E021, 4DU2E022, 4DU2E025, exp 1/31/2021 8 Lots 4DU2E032, 4DU2E033, 4DU2E034, 4DU2E035, 4DU2E036, 4DU2E037, 4DU2E038, 4DU2E039, 4DU2E041, exp 2/28/2021 9 Lots 4DU2E103, 4DU2E101, 4DU2E102, exp 6/30/2021 - Amount recalled
- 476,340 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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