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
Reported: February 1, 2017 Initiated: December 14, 2016 #D-0448-2017
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..
Details
- Recalling Firm
- Roxane Laboratories, Inc.
- Units Affected
- 74,108 bottles
- Distribution
- Nationwide and Puerto Rico.
- Location
- Columbus, OH
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Roxane Laboratories, Inc.. Units affected: 74,108 bottles.
Why was this product recalled? ▼
Defective Delivery System: out of specification result for droplet size distribution at the d90 measurement testing during the 6 month time point..
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 1, 2017. Severity: Low. Recall number: D-0448-2017.
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