Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 10 mg/160 mg/25 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-328-30

Recall Number: D-1144-2018

Firm: Torrent Pharma Inc.

Classification: Class II

Status: Ongoing

Report Date: 20180905

Initiation Date: 20180817

Termination Date:

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 10 mg/160 mg/25 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-328-30