February 2024 FDA Recall Drug by Stason Pharmaceuticals, Inc.
D-0367-2024 - Failed Dissolution Specifications

This Class III drug recall was voluntarily initiated by Stason Pharmaceuticals, Inc. on February 9, 2024 for the product Drug. The FDA reported the reason for recall as failed dissolution specifications. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0367-2024

Reason for Recall
Failed Dissolution Specifications: results slightly under spec at at 9-months.
Initiated
02-09-2024
Reported
03-13-2024
Quantity
54, 131 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
93960
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Stason Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-05-2026
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration 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.