Drug product
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
D-0249-2015
Product summary
- Event
- Event 69572
- Status
- Terminated
- Classification
- Class II
- Quantity
- 16,296 bottles (60-count), 5,166 bottles (250-count)
- Official record key
drug-enforcement:D-0249-2015
Official wording
Reason: Failed Dissolution Specifications: Product found to be out of specification (OOS) during stability testing.
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.
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
out of specification