Class III
Terminated
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
This recall has been terminated (originally issued February 1, 2017).
- Company
- Roxane Laboratories, Inc.
- Recall Initiated
- December 14, 2016
- Posted
- February 1, 2017
- Recall Number
- D-0448-2017
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 74,108 bottles
- Firm Location
- Columbus, OH, United States
- Official Source
- View on FDA website ↗
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
Nationwide and Puerto Rico.
Lot / Code Info
Lot # 659365A, Exp 3/31/2018
More recalls by Roxane Laboratories, Inc.
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