Home / Recalls / Roxane Laboratories, Inc. / D-0448-2017

D-0448-2017 Class III Terminated

Recalled by Roxane Laboratories, Inc. — Columbus, OH

Recall Details

Product Type: Drugs
Report Date: February 1, 2017
Initiation Date: December 14, 2016
Termination Date: December 15, 2017
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 74,108 bottles

Product Description

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 Pattern

Nationwide and Puerto Rico.

Code Information

Lot # 659365A, Exp 3/31/2018