Drug product
Aripiprazole Tablets, USP, 15 mg, 30 tablets per unit dose carton, Rx Only, Manufactured by: Apotex, Inc, Toronto, Ontario Canada M9L 1T9, Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 USA, NDC 0904-6512-04
D-0114-2021
Product summary
- Event
- Event 86787
- Status
- Terminated
- Classification
- Class II
- Quantity
- 841 cartons
- Official record key
drug-enforcement:D-0114-2021
Official wording
Reason: Failed Dissolution Specifications: Out of specification for dissolution.
Code information: Lots: T02520, T02637, exp 02/2021
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Out of specification