Drug product
Mercaptopurine Tablets, USP 50 mg, packaged in: a) 25-count bottle (NDC 69076-913-02), b) 250-count bottle (NDC 69076-913-25), Rx only, Manufactured for: Quinn Pharmaceuticals, Boca Raton, FL, www.quinnrx.com
D-0367-2024
Product summary
- Event
- Event 93960
- Status
- Terminated
- Classification
- Class III
- Quantity
- 54, 131 bottles
- Official record key
drug-enforcement:D-0367-2024
Official wording
Reason: Failed Dissolution Specifications: results slightly under spec at at 9-months.
Code information: Lot #: a)22K012, 22K013A, Exp: 04/30/2024; 23A001, 23A002A, Exp: 07/31/2024; 23D006, 23D007A, 23D007C, Exp:10/31/2024; b)22K013B, Exp: 04/30/2024; 23A002B, Exp:07/31/2024; 23D007B, Exp: 10/31/2024.
Distribution pattern: USA Nationwide
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications