Drug product
Amlodipine and Valsartan Tablets, USP, 10 mg/320 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-204-30
D-1137-2018
Product summary
- Event
- Event 80847
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 89616 bottles
- Official record key
drug-enforcement:D-1137-2018
Official wording
Reason: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Code information: Batch: BV77D013, BV77C011, BV77D001, BV77D002, BV77D003, BV77D004, BV77D005, BV77D006, BV77D007, BV77D008, BV77D009 , BV77D010, BV77D011, BV77D012, BV77C009, BV77C010
Distribution pattern: Nationwide USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations