Azelastine Hydrochloride Nasal Solution (Nasal Spray), 0.1% (137 mcg per spray), packaged in 30 m...
FDA Recall #D-0448-2017 — Class III — December 14, 2016
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..
Recalling Firm
Roxane Laboratories, Inc. — Columbus, OH
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
74,108 bottles
Distribution
Nationwide and Puerto Rico.
Code Information
Lot # 659365A, Exp 3/31/2018
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated