Chemotherapy Tablets Recalled

Stason Pharmaceuticals Inc. is recalling 54,131 bottles of mercaptopurine tablets manufactured for Quinn Pharmaceuticals, Boca Raton, Florida. According to the March 13, 2024, US Food and Drug Administration (FDA) Enforcement Report, samples of the tablets failed to meet dissolution specifications at 9-month testing.

The recall affects the following products, which were distributed throughout the United States:

• mercaptopurine tablets, 50 mg, 25-count bottles (NDC 69076-913-02), from lots 22K012 (Exp. 4/30/24), 22K013A (Exp. 4/30/24), 23A001 (Exp. 7/31/24), 23A002A (Exp. 7/31/24), 23D006 (Exp. 10/31/24), 23D007A (Exp. 10/31/24), and 23D007C (Exp. 10/31/24); and 
• mercaptopurine tablets, 50 mg, 250-count bottles (NDC 69076-913-25), from lots 22K013B (Exp. 4/30/24), 23A002B (Exp. 7/31/24), and 23D007B (Exp. 10/31/24).

Stason Pharmaceuticals voluntarily initiated the recall on February 9, 2024. On March 6, 2024, the FDA designated the recall Class III. The recall classification suggests use of the affected tablets is not likely to cause harm.

Mercaptopurine is a prescription drug indicated for the treatment of adult and pediatric patients with acute lymphoblastic leukemia as part of a combination chemotherapy maintenance regimen.