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U.S. Department of Health and Human Services

Enforcement Report - Week of August 29, 2012

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Product Detail

Product Description 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.
Recall Number D-1659-2012
Classification Class II
Code Info Lot #s: a) 11A003, 11A004, 11A005, Exp 01/13; 11L071, 11L072, Exp 10/13; b) 11B009, Exp 01/13; 11L073, Exp 10/13
Product Distributed Qty a) 25,516 bottles; b) 2,569 bottles
Reason For Recall Failed USP Dissolution Test Requirements: The recalled lots do not meet the specification for dissolution.

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 Letter
Distribution Pattern Nationwide and Puerto Rico.