Drug product
Aripiprazole Tablets, 2 mg, 30 count unit dose box, Rx only, Manufactured by Apotex Inc., Toronto, Ontario, Canada, Distributed by Major Pharmaceuticals, Livonia, MI NDC 0904-6509-04
D-0692-2017
Product summary
- Event
- Event 77105
- Status
- Terminated
- Classification
- Class III
- Quantity
- 36,990 tablets
- Official record key
drug-enforcement:D-0692-2017
Official wording
Reason: Superpotent Drug; out of specification results for assay (manufacturer)
Code information: LOT: T-00601 Exp: 04-2017
Distribution pattern: Nationwide and PR
Derived failure modes
-
Potency or specification failure
Superpotent