Roxane Laboratories, Inc. recalls Azelastine Hydrochloride Nasal Solution (Nasal Spray), 0.1% (137 mcg per spray), packaged in 30 mL bottles, Rx only, Di…

Recall date

December 14, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0448-2017

FDA classification

Class III

Brand / firm

Roxane Laboratories, Inc.

Sold / distributed

Nationwide and Puerto Rico.

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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