Reported Sep 5, 2018 · Ongoing
Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 10 mg/320 mg/25 mg, 30 tablets per bottle, Rx Only,…
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?
- Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 10 mg/320 mg/25 mg, 30 tablets per bottle, Rx Only
- Manufactured byTorrent Pharmaceuticals LTD., Indrad-382 721, India
- NDC13668-325-30
- Lot codes and dates
- Batch
BBX2D025BBX2D026BBX2E001BBX2E002BBX2E003BBX2E004BBX2E005BBX2D003BBX2D004BBX2D005BBX2D006BBX2D007BBX2D008BBX2D015BBX2D016BBX2D017BBX2D018BBX2D019BBX2D020BBX2D021BBX2D022BBX2D023BBX2D024BBX2D001BBX2D002BBX2D009BBX2D010BBX2D011BBX2D012BBX2D013BBX2D014BBX2C007
- Batch
- Amount recalled
- 169,200 bottles
This recall covers 12 products
The agency filed one notice per product. You are reading one of them; the other 11 are below.
Where it was sold
- Nationwide
Why it was recalled
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
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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