Drug product
Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 10 mg/320 mg/25 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-325-30
D-1141-2018
Product summary
- Event
- Event 80847
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 169,200 bottles
- Official record key
drug-enforcement:D-1141-2018
Official wording
Reason: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Code information: Batch: BBX2D025, BBX2D026, BBX2E001, BBX2E002, BBX2E003, BBX2E004, BBX2E005, BBX2D003, BBX2D004, BBX2D005, BBX2D006, BBX2D007, BBX2D008, BBX2D015, BBX2D016, BBX2D017, BBX2D018, BBX2D019, BBX2D020, BBX2D021, BBX2D022, BBX2D023, BBX2D024, BBX2D001, BBX2D002, BBX2D009, BBX2D010, BBX2D011, BBX2D012, BBX2D013, BBX2D014, BBX2C007
Distribution pattern: Nationwide USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations