Drug product
ABILIFY (aripiprazole) Tablets, 30 mg, Rx only, Blister Pack of 100 tablets, Otsuka America Pharmaceutical Inc., Bristol-Myers Squibb NDC 59148-011-35
D-181-2013
Product summary
- Event
- Event 63706
- Status
- Terminated
- Classification
- Class II
- Quantity
- 21 blister packs
- Official record key
drug-enforcement:D-181-2013
Official wording
Reason: CGMP Deviations: A drum of Abilify 30 mg Tablets rejected during the compression stage was not segregated from the other portion of the lot and was inadvertently shipped, packaged and distributed.
Code information: 2E69023A, Exp. FEB 28 2015
Distribution pattern: LA, TN, CA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations