Product: 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
Reason for recall: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Recall initiated: 20180817
Status: Ongoing
Classification: Class II
Recall type: Voluntary: Firm initiated