Reported Feb 27, 2019 · Ongoing
LOSARTAN POTASSIUM TABLETS, USP, 100 mg, a) 30-count (NDC: 13668-115-30), b) 90-count (NDC: 13668-115-90), c)…
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. · 1803 Whites Rd Ste 1 · Kalamazoo, MI · 49008-2883
Is this the product you have?
- LOSARTAN POTASSIUM TABLETS, USP, 100 mg
- a) 30-count (NDC13668-115-30)
- b) 90-count (NDC13668-115-90)
- c) 1000-count (NDC13668-115-10) per bottle, Rx only
- Manufactured byTorrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana Inda
- Lot codes and dates
- Count, lots
- expiry
[30-count bottle] Lot BO31C016exp 04/2019[90-count bottle] Lot BO31C016exp 04/2019[1000-count bottle] Lots 4DK3C0044DK3C005exp 04/2019Lots 4DU3C040exp 10/2019Lots 4DU3E0494DU3E050exp 05/2021
- Amount recalled
- 83,016 bottles
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
- Nationwide
- PR
Why it was recalled
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
This product could cause temporary or reversible health problems — stop using it.
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