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 |
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