Drug product
Valsartan Tablets USP, 40 mg, 30-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd Roorkee 0247661 India, Marketed by: Jubilant Cardista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC 59746-360-30
D-1103-2018
Product summary
- Event
- Event 80836
- Status
- Terminated
- Classification
- Class III
- Quantity
- 10,577 bottles
- Official record key
drug-enforcement:D-1103-2018
Official wording
Reason: Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.
Code information: Lot #: VR117014A, VR117015A, Exp. 08/2019
Distribution pattern: Product was distributed throughout the United States to wholesalers and retailers.
Derived failure modes
-
Unknown
Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.