FDA-Drug2018-09-05Class II
Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 10 mg/160 mg/12.5 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-327-30
Torrent Pharma Inc.
Hazard
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Sold states
Nationwide USA
Affected count
22704 bottles
Manufactured in
150 Allen Rd Ste 102, N/A, Basking Ridge, NJ, United States
Products
Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 10 mg/160 mg/12.5 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-327-30
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1143-2018Don't want to check this manually?
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