Drug product
Irbesartan Tablets, USP, 150mg, 90- count bottles, Rx only, Manufactured by: Jubilant Generics Ltd. Roorkee- 247661, India, Marketed by: Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC 59746-448-90
D-1293-2022
Product summary
- Event
- Event 90610
- Status
- Terminated
- Classification
- Class II
- Quantity
- 9,600 bottles
- Official record key
drug-enforcement:D-1293-2022
Official wording
Reason: Failed dissolution specifications.
Code information: Lot #: IB220023A, exp. date 08/2022
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Potency or specification failure
Failed dissolution specifications