Reported May 8, 2019 · Ongoing
Losartan Potassium and Hydrochlorothiazide Tablets, USP, 100mg/12.5mg, a) 90-count (NDC: 13668-117-90), b) 1000-count…
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 and Hydrochlorothiazide Tablets, USP, 100mg/12.5mg
- a) 90-count (NDC13668-117-90)
- b) 1000-count (NDC13668-117-10), 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 BX35D024exp 1/31/2020BEF8D060BEF8D061BEF8D062BEF8D063BEF8D064exp 11/30/2020[1000-count bottle] Lot BEF8D059exp 11/30/2020Lots BEF8E004BEF8E005exp 1/31/2021
- Amount recalled
- 54,084 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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