FDA recall D-181-2013

Product

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

LA, TN, CA

Key facts

Status

Terminated

Initiation date

2012-11-02

Report date

2013-03-13

Termination date

2013-05-02

Voluntary/Mandated

Voluntary: Firm initiated

Location

Humacao, PR, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-181-2013