Home / Recalls / Stason Pharmaceuticals, Inc. / D-0367-2024

D-0367-2024 Class III Terminated

Recalled by Stason Pharmaceuticals, Inc. — Irvine, CA

Recall Details

Product Type: Drugs
Report Date: March 13, 2024
Initiation Date: February 9, 2024
Termination Date: February 5, 2026
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 54, 131 bottles

Product Description

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 for Recall

Failed Dissolution Specifications: results slightly under spec at at 9-months.

Distribution Pattern

USA Nationwide

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.