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U.S. Department of Health and Human Services

Enforcement Report - Week of March 13, 2013

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Product Detail

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
Recall Number D-181-2013
Classification Class II
Code Info 2E69023A, Exp. FEB 28 2015
Product Distributed Qty 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.

Event Detail

Event Id 63706
Product Type Drugs
Status Ongoing
Recalling Firm Bristol Myers Squibb Manufacturing Company
City Humacao
State PR
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-11-02
Initial Firm Notification of Consignee or Public Telephone
Distribution Pattern LA, TN, CA