D-181-2013 Class II Terminated

Recalled by Bristol Myers Squibb Manufacturing Company — Humacao, PR

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