FDA Drug recall D-0367-2024
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, Man…
- FDA Drug
- Class III
- terminated
- Published 2024-03-13
On 2024-03-13 the FDA classified a Class III recall of 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, Man… by Stason Pharmaceuticals, citing failed Dissolution Specifications: results slightly under spec at at 9-months.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0367-2024 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2024-02-09 |
| Published | 2024-03-13 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Stason Pharmaceuticals |
| Distribution | US |
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
Reason
Failed Dissolution Specifications: results slightly under spec at at 9-months.
Identifiers
| code_info | Lot #: a)22K012, 22K013A, Exp: 04/30/2024; 23A001, 23A002A, Exp: 07/31/2024; 23D006, 23D007A, 23D007C, Exp:10/31/2024;…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0367-2024%22
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