Defective Nasal Spray Recalled

Glenmark Pharmaceuticals Inc. USA is recalling more than 45 000 bottles of Ryaltris nasal spray because of a defective delivery system. According to the October 9, 2024, US Food and Drug Administration (FDA) Enforcement Report, the product’s dip tube is clogged, preventing it from spraying.

The recall affects Ryaltris (olopatadine hydrochloride and mometasone furoate) nasal spray, 665 mcg/25 mcg per spray, 240 metered sprays/bottle (NDC 59467-700-27), from lots 14230425 (Exp. 11/25), 14240024 (Exp. 12/25), 14240029 (Exp. 12/25), 14240076 (Exp. 1/26), 14240082 (Exp. 1/26), 14240090 (Exp. 1/26), and 14240100 (Exp. 1/26). The nasal spray was distributed by Hikma Specialty USA Inc., Columbus, Ohio, within the United States.

Glenmark Pharmaceuticals initiated the recall on September 24, 2024. On October 3, 2024, the FDA designated the recall Class II, communicating use of the product may cause temporary or medically reversible adverse health consequences or a remote possibility of serious harm.

Ryaltris is a prescription nasal spray indicated for the treatment of symptoms of seasonal allergic rhinitis in adult and pediatric patients aged 12 years and older.