Drug product
Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 5 mg/160 mg/12.5 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-326-30
D-1142-2018
Product summary
- Event
- Event 80847
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 50,784 bottles
- Official record key
drug-enforcement:D-1142-2018
Official wording
Reason: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Code information: Batch: BBY1E001, BBY1E003, BBY1C002, BBY1E002, BBY1D001
Distribution pattern: Nationwide USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations