Drug product
Valsartan Tablets USP 40 mg 30 Scored Tablets Rx Only NDC 59746-360-30 Manufactured by: Jubilant Generics Ltd. Roorkee-247661, India
D-0461-2021
Product summary
- Event
- Event 87512
- Status
- Terminated
- Classification
- Class II
- Quantity
- 20 bottles
- Official record key
drug-enforcement:D-0461-2021
Official wording
Reason: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Code information: VR120022A
Distribution pattern: FL, GA, SC
Derived failure modes
-
Manufacturing or process control
CGMP Deviations