ABILIFY (aripiprazole) Tablets, 30 mg, Rx only, Blister Pack of 100 tablets, Otsuka America Pharm...
FDA Recall #D-181-2013 — Class II — November 2, 2012
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.
Recalling Firm
Bristol Myers Squibb Manufacturing Company — Humacao, PR
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
21 blister packs
Distribution
LA, TN, CA
Code Information
2E69023A, Exp. FEB 28 2015
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated