Nasal Spray Recalled Over Defective Bottles

Mylan Pharmaceuticals Inc. is recalling 10,390 bottles of Dymista (azelastine hydrochloride and fluticasone propionate) nasal spray because of the potential for broken glass in the bottle. The recall was included in the February 13, 2019, US Food and Drug Administration (FDA) Enforcement Report. 

The recall affects Dymista, 137 mcg/50 mcg per spray, 120 metered sprays, 23 g net fill weight bottles (NDC 0037-0245-23) from lot GA70535 (Exp. 4/19). The bottles were manufactured for Meda Pharmaceuticals by Cipla Ltd. and distributed throughout the United States.

Mylan Pharmaceuticals voluntarily initiated the recall February 1, 2019. The FDA designated the recall Class II February 4, 2019, signaling use of the affected nasal spray could cause temporary or medically reversible adverse health consequences. A remote possibility of serious harm also exists.

Dymista is a prescription nasal spray used to relieve sneezing, runny nose, and other symptoms of seasonal allergies.

 —Jolynn Tumolo