RecallDepth
Class II Terminated

Mercaptopurine Tablets, USP 50mg, a) 60-count bottle (NDC 49884-922-02), b) 250-count bottle (NDC 49884-922-04), RX only, Manufactured by Stason Pharmaceuticals, Inc., 11 Morgan, Irvine, CA 92618 for Prometheus Laboratories, Inc., 9410 Carroll Park Drive, San Diego, CA 92121

Company
Prometheus Laboratories Inc.
Recall Initiated
October 22, 2014
Posted
November 26, 2014
Recall Number
D-0249-2015
Voluntary / Mandated
Voluntary: Firm initiated
Quantity
16,296 bottles (60-count), 5,166 bottles (250-count)
Firm Location
San Diego, CA, United States

Reason for Recall

Failed Dissolution Specifications: Product found to be out of specification (OOS) during stability testing.

Distribution

Nationwide

Lot / Code Info

Mercaptopurine Tablets, USP 50mg, a) 60-count bottle (NDC 49884-922-02), b) 250-count bottle (NDC 49884-922-04), RX only, Manufactured by Stason Pharmaceuticals, Inc., 11 Morgan, Irvine, CA 92618 for Prometheus Laboratories, Inc., 9410 Carroll Park Drive, San Diego, CA 92121 Lot #: a) 140B11, Exp Feb 2016; 14B012, Exp Feb 2016; 14B013, Exp Feb 2016 Lot #: b) 13F046, Exp Jun 2015; 13K073, Exp Oct 2015; 13L075, Exp Oct 2015; 14B010, Exp Feb 2016.

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