Drug product
Olanzapine Orally Disintegrating Tablets, 5 mg, 30 count (3x10 unit dose) blister pack, Rx only, Manufactured by: Jubilant Generics, Ltd., Roorkee, India, Marketed by: Jubilant Cardista Pharmaceuticals, Inc., Salisbury, MD NDC 59746-0306-32
D-0066-2021
Product summary
- Event
- Event 86658
- Status
- Terminated
- Classification
- Class III
- Quantity
- 23,616 blister packs
- Official record key
drug-enforcement:D-0066-2021
Official wording
Reason: Subpotent
Code information: Lot # AE119001A, exp. date 01/2021
Distribution pattern: Product was distributed nationwide
Derived failure modes
-
Potency or specification failure
Subpotent