Azelastine Hydrochloride Nasal Solution (Nasal Spray)…

Date

Feb. 1, 2017

Risk class

Class III (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences)

Status

Terminated

Filed by

Roxane Laboratories, Inc.

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

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

Distribution pattern

Nationwide and Puerto Rico.

Quantity

74,108 bottles

Codes and lots

Lot # 659365A, Exp 3/31/2018

Recall started

Dec. 14, 2016

Recall number

D-0448-2017

What should I do? Medicine recall: what to do

Source: FDA · Drug enforcement report, recall number D-0448-2017. The agency record governs; check it and the company before acting.