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
Reported: March 13, 2024 Initiated: February 9, 2024 #D-0367-2024
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.
Details
- Recalling Firm
- Stason Pharmaceuticals, Inc.
- Units Affected
- 54, 131 bottles
- Distribution
- USA Nationwide
- Location
- Irvine, CA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Stason Pharmaceuticals, Inc.. Units affected: 54, 131 bottles.
Why was this product recalled? ▼
Failed Dissolution Specifications: results slightly under spec at at 9-months.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 13, 2024. Severity: Low. Recall number: D-0367-2024.
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