Drug product
Amlodipine and Valsartan Tablets, USP, 5 mg/160 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-207-30
D-1140-2018
Product summary
- Event
- Event 80847
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 78144 bottles
- Official record key
drug-enforcement:D-1140-2018
Official wording
Reason: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Code information: Batch: BV53D004, BV53C006, BV53D001, BV53D002, BV53D003, BV53C004, BV53C005
Distribution pattern: Nationwide USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations