Status
Terminated
Drug Enforcement D-181-2013
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.
Classification
Class II
Report Date
March 13, 2013
Termination Date
May 2, 2013
Product Information
- Product description
- ABILIFY (aripiprazole) Tablets, 30 mg, Rx only, Blister Pack of 100 tablets, Otsuka America Pharmaceutical Inc., Bristol-Myers Squibb NDC 59148-011-35
- Product quantity
- 21 blister packs
- Reason for recall
- 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.
- Recall initiation reason
- —
- Initial firm notification
- Telephone
- Distribution pattern
- LA, TN, CA
Location & Firm
- Recalling firm
- Bristol Myers Squibb Manufacturing Company
- Address
-
Rd #3 Km 77.5, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-181-2013
- Event ID
- 63706
- Recall initiation date
- November 2, 2012
- Center classification date
- March 4, 2013
- Code info
- 2E69023A, Exp. FEB 28 2015
- More code info
- —