Drug product
Donepezil HCL Tablets, USP, 5 mg, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd. India, Marketed by: Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD 21801 NDC 59746-329-90
D-0784-2021
Product summary
- Event
- Event 88523
- Status
- Terminated
- Classification
- Class III
- Quantity
- 14,544 bottles
- Official record key
drug-enforcement:D-0784-2021
Official wording
Reason: Subpotent
Code information: Lot # DN120006A, exp. date 12/2021
Distribution pattern: Product was distributed nationwide.
Derived failure modes
-
Potency or specification failure
Subpotent