Nasal Spray Recalled

Ingenus Pharmaceuticals is recalling 6176 bottles of flunisolide nasal solution for failing to meet impurity specifications, according to the October 26, 2022, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects flunisolide nasal solution 0.025%, 25-mL bottles (NDC 50742-317-25, UPC 3 50742 31725 7), from lots 22E040 (Exp. 7/23) and 22F038 (Exp. 8/23). The solution was manufactured for Ingenus Pharmaceuticals, Orlando, FL, and distributed throughout the United States.

Ingenus Pharmaceuticals voluntarily initiated the recall September 30, 2022. On October 17, 2022, the FDA designated the recall Class II, signaling use of the product could cause temporary or medically reversible adverse health consequences. A remote possibility of serious harm also exists.

Flunisolide a prescription nasal spray indicated for the treatment of seasonal or perennial rhinitis.