Drug product
Valsartan Tablets USP, 160mg, 90 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-069-90
D-1135-2018
Product summary
- Event
- Event 80847
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 14016 bottles
- Official record key
drug-enforcement:D-1135-2018
Official wording
Reason: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Code information: Batch: BV47C005, BV47C006, BV47D001, BV47C003, BV47C004
Distribution pattern: Nationwide USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations