FDA recall D-0424-2019

Product

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.

Reason for recall

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

Distribution

Nationwide in the USA.

Key facts

Status

Terminated

Initiation date

2019-02-01

Report date

2019-02-13

Termination date

2019-09-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

Morgantown, WV, United States

Primary source

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