Reported Oct 9, 2019 · Ongoing
Losartan Potassium Tablets, USP 100 mg, [90 or 1000] tablets per bottle, Rx Only, Manufactured for: Torrent Pharma…
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, [90 or 1000] tablets per bottle, Rx Only
- Manufactured forTorrent Pharma Inc., Basking Ridge, NJ 07920
- NDC 90 tablets13668-115-90
- NDC 1000 tablets13668-115-10
- Lot codes and dates
- Count, lot
- expiry
[90 count] Lot 4DU3E009exp 12/31/2020[1000 count] Lot 4DU3D018exp 02/28/2021
- Amount recalled
- 39,432 bottles
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 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 of 9.82 parts per million.
This product could cause temporary or reversible health problems — stop using it.
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