Drug product
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.
D-1659-2012
Product summary
- Event
- Event 62772
- Status
- Terminated
- Classification
- Class II
- Quantity
- a) 25,516 bottles; b) 2,569 bottles
- Official record key
drug-enforcement:D-1659-2012
Official wording
Reason: Failed USP Dissolution Test Requirements: The recalled lots do not meet the specification for dissolution.
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
Distribution pattern: Nationwide and Puerto Rico.
Derived failure modes
-
Unknown
Failed USP Dissolution Test Requirements: The recalled lots do not meet the specification for dissolution.