Irvine, CA, United States
Stason Pharmaceuticals, Inc. recalls
1 recall recorded since 2018, most recently on 9 February 2024. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class III Drugs
- Recall started
- 9 February 2024
- Terminated
- 5 February 2026
- Reason
- Failed Dissolution Specifications: results slightly under spec at at 9-months.
- Distribution
- USA Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0367-2024
- 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
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.