FDA-Drug2017-02-01Class III
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
Roxane Laboratories, Inc.
Hazard
Defective Delivery System: out of specification result for droplet size distribution at the d90 measurement testing during the 6 month time point..
Sold states
Nationwide and Puerto Rico.
Affected count
74,108 bottles
Manufactured in
1809 Wilson Rd, N/A, Columbus, OH, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0448-2017Don't want to check this manually?
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