FDA recall D-1075-2018

Product

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

Reason for recall

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

Distribution

U.S. Nationwide

Key facts

Status

Terminated

Initiation date

2018-07-25

Report date

2018-08-15

Termination date

2019-08-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Morgantown, WV, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1075-2018