Stason Pharmaceuticals, Inc.: Drug Recall

Recall #D-0367-2024 · 02/09/2024

Class III: Low Risk

Recall Details

Recall Number
D-0367-2024
Classification
Class III
Product Type
Drug
Recalling Firm
Stason Pharmaceuticals, Inc.
Status
Terminated
Date Initiated
02/09/2024
Location
Irvine, CA, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
54, 131 bottles

Reason for Recall

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

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

Distribution Pattern

USA Nationwide

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.