Torrent Pharma Inc. recalls Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 10 mg/320 mg/25 mg, 30 tablets per bottle, Rx Only, Manufact
Recalled September 5, 2018 · FDA recall D-1141-2018 · Torrent Pharma
Hazard
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. · FDA Class II
Units
169,200 bottles
Sold at
Nationwide USA
Description
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Product
Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 10 mg/320 mg/25 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-325-30
Manufacturer(s)
Torrent Pharma Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →