Drug product
Valsartan Tablets USP 160 mg, 100 Tablets (10 x 10) per Unit Dose Blisters, Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217 (Individual Dose NDC:60687-139-11, Carton NDC#: 60687-139-01)
D-1047-2019
Product summary
- Event
- Event 82316
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3337 cartons
- Official record key
drug-enforcement:D-1047-2019
Official wording
Reason: CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient.
Code information: Lot 179791, Mar 2020
Distribution pattern: Nationwide USA and Puerto Rico
Derived failure modes
-
Foreign material or chemical contamination
NDEA (N-Nitrosodimethylamine), a carcinogen impurity
-
Manufacturing or process control
CGMP Deviation