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.
More recalls by Prometheus Laboratories Inc.
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