Reported May 8, 2019 · Ongoing
Losartan Potassium Tablets, USP, 25 mg, a) 90-count (NDC: 13668-113-90), b)1000-count (NDC: 13668-113-10) 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, 25 mg
- a) 90-count (NDC13668-113-90)
- b)1000-count (NDC13668-113-10) per bottle, Rx only
- Manufactured byTorrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India
- Lot codes and dates
- Count, lots
- expiry
[90-count bottle] Lot BDK1C003exp 07/31/2019[1000-count bottle] Lot BDK1C002exp 07/31/2019Lots 4DU1D0044DU1D0054DU1D006exp 12/31/2019
- Amount recalled
- 28,464 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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