Reported May 8, 2019 · Ongoing
Losartan Potassium Tablets, USP, 100 mg, a) 90-count (NDC: 13668-115-90), b)1000-count (NDC: 13668-115-10) 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, 100 mg
- a) 90-count (NDC13668-115-90)
- b)1000-count (NDC13668-115-10) per bottle, Rx only
- Manufactured byTorrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India
- Lot codes and dates
7 of 7 products
Products covered by this recall # Product as published 1 [90-count bottle] Lot 4DU3E016, exp 01/31/2021 2 [1000-count bottle] Lot 4DU3C012, exp 7/31/2019 3 Lots 4DU3C015, 4DU3C016, 4DU3C017, exp 8/31/2019 4 Lot 4DU3C031, exp 9/30/2019 5 Lots 4DU3D007, 4DU3D008, exp 1/31/2020 6 Lot 4DU3E017, exp 1/31/2021 7 Lot 4DU3E019, exp 2/28/2021 - Amount recalled
- 65,184 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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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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