Drug product
Aripiprazole Tablets, 2 mg, 30-count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9L 1T9; Manufactured for: Apotex Corp., Weston, Florida 33326, NDC 60505-3075-3.
D-0471-2017
Product summary
- Firm
- Apotex Inc.
- Event
- Event 75984
- Status
- Terminated
- Classification
- Class III
- Quantity
- 67,946 bottles
- Official record key
drug-enforcement:D-0471-2017
Official wording
Reason: Superpotent Drug: Product may not meet specifications throughout shelf life.
Code information: Lot #: MJ7746, Exp 04/17
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Superpotent