Drug product
Mercaptopurine Tablets, USP, 50 mg, 30 Tablets (3 x 10) unit dose blisters per carton, Rx only, Packaged by American Health Packaging, 2550-A John Glenn Avenue, Columbus, OH 43217, barcode 6808432511; Carton labeling Dist by: Par Pharmaceutical Companies, Inc., Spring Valley, NY 10977, NDC 68084-325-21.
D-1668-2012
Product summary
- Event
- Event 62748
- Status
- Terminated
- Classification
- Class II
- Quantity
- 694 cartons
- Official record key
drug-enforcement:D-1668-2012
Official wording
Reason: Failed USP Dissolution Test Requirements: This sub-recall is in response to Prometheus Laboratories Inc. recall for Mercaptopurine USP 50mg because the lot does not meet the specification for dissolution.
Code information: Lot #: 120604 Exp 2/28/2013
Distribution pattern: Nationwide.
Derived failure modes
-
Potency or specification failure
does not meet the specification