Mercaptopurine Tablets, USP 50 mg, packaged in: a) 25-count bottle (NDC 69076-913-02), b) 250-count bottle (NDC 69076-91
Summary
The FDA issued a Class III for Mercaptopurine Tablets, USP 50 mg, packaged in: a) 25-count bottle (NDC 69076-91 by Stason Pharmaceuticals, Inc.. Reason: Failed Dissolution Specifications: results slightly under spec at at 9-months..
Details
Source
Drug Recall
External ID
D-0367-2024
Action Date
2024-03-13
Status
Terminated
Category
drug
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
Lot/Code Info: 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.
Quantity Affected: 54, 131 bottles
Reason for Recall
Failed Dissolution Specifications: results slightly under spec at at 9-months.
Distribution
USA Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2024-02-09
Company
Irvine, CA
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 36 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Stason Pharmaceuticals, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Stason Pharmaceuticals, Inc. have FDA actions?
This is the only FDA action we have on record for Stason Pharmaceuticals, Inc. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0367-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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