FDA recall D-0448-2017

Product

Azelastine Hydrochloride Nasal Solution (Nasal Spray), 0.1% (137 mcg per spray), packaged in 30 mL bottles, Rx only, Distributed by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 07724, NDC 0054-0293-99

Reason for recall

Defective Delivery System: out of specification result for droplet size distribution at the d90 measurement testing during the 6 month time point..

Distribution

Nationwide and Puerto Rico.

Key facts

Status

Terminated

Initiation date

2016-12-14

Report date

2017-02-01

Termination date

2017-12-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Columbus, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0448-2017