FDAFDA · Food and drugs·Recall number D-1659-2012
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.
Published August 29, 2012 · Recall initiated: June 29, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed USP Dissolution Test Requirements: The recalled lots do not meet the specification for dissolution.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Prometheus Laboratories Inc.
- Distributor
- Nationwide and Puerto Rico.
- Lot
- Lot #s: a) 11A003, 11A004, 11A005, Exp 01/13; 11L071, 11L072, Exp 10/13; b) 11B009, Exp 01/13; 11L073, Exp 10/13
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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