Prometheus Laboratories Inc. recalls Mercaptopurine Tablets, USP, 50 mg, packaged in a) 60-count tablets per bottle (NDC 49884-922-02) and b) 250-count table
Recalled August 29, 2012 · FDA recall D-1659-2012 · Prometheus Laboratories
Hazard
Failed USP Dissolution Test Requirements: The recalled lots do not meet the specification for dissolution. · FDA Class II
Units
a) 25,516 bottles; b) 2,569 bottles
Sold at
Nationwide and Puerto Rico.
Description
Failed USP Dissolution Test Requirements: The recalled lots do not meet the specification for dissolution.
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.
Manufacturer(s)
Prometheus Laboratories Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →