D-181-2013 Class II Terminated
FDA drug recall D-181-2013 was initiated by Bristol Myers Squibb Manufacturing Company on November 2, 2012 and is designated Class II. 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. The recall status is terminated (terminated May 2, 2013). Affected quantity: 21 blister packs.
Recall Details
- Product Type
- Drugs
- Report Date
- March 13, 2013
- Initiation Date
- November 2, 2012
- Termination Date
- May 2, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 21 blister packs
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
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.
Distribution Pattern
LA, TN, CA
Code Information
2E69023A, Exp. FEB 28 2015