FDA-Drug2019-02-13Class II

Dymista (azelastine hydrochloride and fluticasone propionate) Nasal Spray, 137 mcg/50 mcg per spray, 120 Metered Sprays, 23 g net fill weight bottle, Rx Only, Manufactured by: Cipla Ltd., Goa, India, M.L. No. 546; For: Meda Pharmaceuticals Inc., Somerset, New Jersey 08873-4120, NDC 0037-0245-23.

Mylan Pharmaceuticals Inc.
Hazard

Defective Container: Potential for broken glass in the neck area of the glass bottles.

Sold states
Nationwide in the USA.
Affected count
10,390 bottles
Manufactured in
781 Chestnut Ridge Rd, Morgantown, WV, United States
Products
Dymista (azelastine hydrochloride and fluticasone propionate) Nasal Spray, 137 mcg/50 mcg per spray, 120 Metered Sprays, 23 g net fill weight bottle, Rx Only, Manufactured by: Cipla Ltd., Goa, India, M.L. No. 546; For: Meda Pharmaceuticals Inc., Somerset, New Jersey 08873-4120, NDC 0037-0245-23.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0424-2019

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