Roxane Laboratories, Inc. recalls Azelastine Hydrochloride Nasal Solution (Nasal Spray), 0.1% (137 mcg per spray), packaged in 30 mL bottles, Rx only, Dis
Recalled February 1, 2017 · FDA recall D-0448-2017 · Roxane Laboratories
Hazard
Defective Delivery System: out of specification result for droplet size distribution at the d90 measurement testing during the 6 month time point.. · FDA Class III
Units
74,108 bottles
Sold at
Nationwide and Puerto Rico.
Description
Defective Delivery System: out of specification result for droplet size distribution at the d90 measurement testing during the 6 month time point..
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
Manufacturer(s)
Roxane Laboratories, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →