Drug product
Mercaptopurine Tablets, USP, 50 mg, 30 Tablets (3 x 10) unit dose blisters per carton, Rx only, Manufactured by Prometheus Laboratories Inc. 9410 Carroll Park Drive, San Diego, CA 92121, repackaged by American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217, NDC 68084-325-21
D-0300-2015
Product summary
- Event
- Event 69972
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3496 cartons
- Official record key
drug-enforcement:D-0300-2015
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 #: 142450 Exp 05/2015; 140862 Exp 02/2015; 141596 Exp 03/2015; 134770 Exp 01/2015
Distribution pattern: Nationwide.
Derived failure modes
-
Potency or specification failure
does not meet the specification