FDAFDA · Food and drugs·Recall number D-0448-2017
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
Published February 1, 2017 · Recall initiated: December 14, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Defective Delivery System: out of specification result for droplet size distribution at the d90 measurement testing during the 6 month time point..
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Roxane Laboratories, Inc.
- Distributor
- Nationwide and Puerto Rico.
- Lot
- Lot # 659365A, Exp 3/31/2018
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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