Stason Pharmaceuticals, Inc. recalls Mercaptopurine Tablets, USP 50 mg, packaged in: a) 25-count bottle (NDC 69076-913-02), b) 250-count bottle (NDC 69076-9…
- Recall date
- February 9, 2024
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0367-2024
- FDA classification
- Class III
- Brand / firm
- Stason Pharmaceuticals, Inc.
- Sold / distributed
- USA Nationwide
Why it was recalled
Failed Dissolution Specifications: results slightly under spec at at 9-months.
Class III means the product violates regulations but is not likely to cause harm.
What 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
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