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U.S. Department of Health and Human Services

Enforcement Report - Week of March 13, 2013

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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

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
ABILIFY (aripiprazole) Tablets, 30 mg, Rx only, Blister Pack of 100 tablets, Otsuka America Pharmaceutical Inc., Bristol-Myers Squibb NDC 59148-011-35 2E69023A, Exp. FEB 28 2015 Class II 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. 21 blister packs D-181-2013
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