Mylan Pharmaceuticals Inc. recalls Dymista (azelastine hydrochloride and fluticasone propionate) Nasal Spray, 137 mcg / 50 mcg per spray, packaged in a 23…

Recall date

July 25, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-1075-2018

FDA classification

Class II

Brand / firm

Mylan Pharmaceuticals Inc.

Sold / distributed

U.S. Nationwide

Why it was recalled

Presence of foreign substance: Potential for glass in the neck area of the glass bottles.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Dymista (azelastine hydrochloride and fluticasone propionate) Nasal Spray, 137 mcg / 50 mcg per spray, packaged in a 23 g net fill weight, Rx only, Manufactured by: Cipla Ltd., Goa, India, M.L.,, NDC 0037-0245-23