Mercaptopurine Tablets, USP 50 mg, packaged in: a) 25-count bottle (NDC 69076-913-02), b) 250-cou...
FDA Recall #D-0367-2024 — Class III — February 9, 2024
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.
Recalling Firm
Stason Pharmaceuticals, Inc. — Irvine, CA
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
54, 131 bottles
Distribution
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.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated