← FDA ENFORCEMENT
D-0367-2024Class III

Stason Pharmaceuticals, Inc.

Recalling firm
Stason Pharmaceuticals, Inc.
Product type
Drug
Status
Terminated
Report date
2024-03-13
Distribution
USA Nationwide
Firm state
CA
Product quantity
54, 131 bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & Qualification
Reason for recall

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

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

Code / lot 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.

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.