D-1659-2012 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- August 29, 2012
- Initiation Date
- June 29, 2012
- Termination Date
- March 27, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- a) 25,516 bottles; b) 2,569 bottles
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.
Reason for Recall
Failed USP Dissolution Test Requirements: The recalled lots do not meet the specification for dissolution.
Distribution Pattern
Nationwide and Puerto Rico.
Code Information
Lot #s: a) 11A003, 11A004, 11A005, Exp 01/13; 11L071, 11L072, Exp 10/13; b) 11B009, Exp 01/13; 11L073, Exp 10/13