Class II
Terminated
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.
This recall has been terminated (originally issued August 29, 2012).
- Company
- Prometheus Laboratories Inc.
- Recall Initiated
- June 29, 2012
- Posted
- August 29, 2012
- Recall Number
- D-1659-2012
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- a) 25,516 bottles; b) 2,569 bottles
- Firm Location
- San Diego, CA, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Failed USP Dissolution Test Requirements: The recalled lots do not meet the specification for dissolution.
Distribution
Nationwide and Puerto Rico.
Lot / 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
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