FDA Recall Ongoing Historical recordClass II
Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 5 mg/160 mg/25 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-329-30
- Reason
- CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- Published
- September 5, 2018
- Distribution
- Nationwide
