December 2016 FDA Recall Drug by Roxane Laboratories, Inc.
D-0448-2017 - Defective Delivery System
This Class III drug recall was voluntarily initiated by Roxane Laboratories, Inc. on December 14, 2016 for the product Drug. The FDA reported the reason for recall as defective delivery system. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0448-2017
Defective Delivery System: out of specification result for droplet size distribution at the d90 measurement testing during the 6 month time point..
12-14-2016
02-01-2017
74,108 bottles
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Roxane Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and Puerto Rico.
12-15-2017
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# 659365A, Exp 3/31/2018
