Drug product
Valsartan Tablets USP, 320 mg, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd Roorkee 0247661 India, Marketed by: Jubilant Cardista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC 59746-363-90
D-1106-2018
Product summary
- Event
- Event 80836
- Status
- Terminated
- Classification
- Class III
- Quantity
- 7,048 bottles
- Official record key
drug-enforcement:D-1106-2018
Official wording
Reason: Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.
Code information: Lot #: VR417062A, Exp. 09/2019; VR417063A, VR417064A, Exp. 10/2019
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.