D-0249-2015 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- November 26, 2014
- Initiation Date
- October 22, 2014
- Termination Date
- February 18, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 16,296 bottles (60-count), 5,166 bottles (250-count)
Product Description
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
Reason for Recall
Failed Dissolution Specifications: Product found to be out of specification (OOS) during stability testing.
Distribution Pattern
Nationwide
Code Information
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.