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
This recall has been terminated (originally issued November 26, 2014).
- 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
- Official Source
- View on FDA website ↗
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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