Class III
Terminated
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
This recall has been terminated (originally issued March 13, 2024).
- Company
- Stason Pharmaceuticals, Inc.
- Recall Initiated
- February 9, 2024
- Posted
- March 13, 2024
- Recall Number
- D-0367-2024
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 54, 131 bottles
- Firm Location
- Irvine, CA, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Failed Dissolution Specifications: results slightly under spec at at 9-months.
Distribution
USA Nationwide
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.
More recalls by Stason Pharmaceuticals, Inc.
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