FDA-Drug2024-03-13Class III

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

Stason Pharmaceuticals, Inc.
Hazard

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

Sold states
USA Nationwide
Affected count
54, 131 bottles
Manufactured in
11 Morgan, Irvine, CA, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0367-2024

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