Reported Apr 17, 2019 · Ongoing
LOSARTAN POTASSIUM TABLETS, USP, 100 mg, a) 90-count (NDC: 13668-115-90), b) 1000-count (NDC: 13668-115-10), per…
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
- ForTorrent Pharma, Inc, 150 Allen Road, Suite 102, Basking Ridge, NJ
- Lot codes and dates
- Count, lots
- expiry
[90-count bottle] Lots 4DU3E0144DU3E015exp 1/31/2021Lot 4DU3E065exp 7/31/2021[1000-count bottle] Lot 4DU3D018exp 11/30/2020Lots 4DU3E0624DU3E063exp 6/30/2021
- Amount recalled
- 121,668 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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