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

Recall Number: D-0448-2017

Firm: Roxane Laboratories, Inc.

Classification: Class III

Status: Terminated

Report Date: 20170201

Initiation Date: 20161214

Termination Date: 20171215

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

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