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U.S. Department of Health and Human Services

Enforcement Report - Week of August 29, 2012

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Event Detail

Event ID 62772
Product Type Drugs
Status Ongoing
Recalling Firm Prometheus Laboratories Inc.
City San Diego
State CA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-06-29
Initial Firm Notification of
Consignee or Public
Distribution Pattern Nationwide and Puerto Rico.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Mercaptopurine Tablets, USP, 50 mg, packaged in a) 60-count tablets per bottle (NDC 49884-922-02) and b) 250-count tablets per bottle (NDC 49884-922-04), Rx only, Distributed by: Par Pharmaceutical Companies, Inc., Spring Valley, NY 10977. Lot #s: a) 11A003, 11A004, 11A005, Exp 01/13; 11L071, 11L072, Exp 10/13; b) 11B009, Exp 01/13; 11L073, Exp 10/13 Class II Failed USP Dissolution Test Requirements: The recalled lots do not meet the specification for dissolution. a) 25,516 bottles; b) 2,569 bottles D-1659-2012