Reported Apr 17, 2019 · Ongoing
Losartan Potassium / Hydrochlorothiazide Tablets, USP 100mg/12.5mg, a) 30-count (NDC: 13668-117-30), b) 90-count (NDC:…
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 / Hydrochlorothiazide Tablets, USP 100mg/12.5mg
- a) 30-count (NDC13668-117-30)
- b) 90-count (NDC13668-117-90) 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[30-count bottle] Lot BEF8D058,exp 11/30/2020 [90-count bottle] Lots BEF8D009, BEF8D010, BEF8D011, BEF8D012, BEF8D013, BEF8D007, BEF8D008, exp 3/31/2020; Lots BEF8D023, BEF8D024, BEF8D025, BEF8D020, BEF8D021, BEF8D022, exp 4/30/2020; Lots BEF8D054, BEF8D055, BEF8D056, exp 10/31/2020; Lots BEF8D057, exp 11/30/2020
- Amount recalled
- 172,296 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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