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FDADecember 14, 2016drug

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 recall recorded by the U.S. Food & Drug Administration.

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

FDA enforcement status: Terminated

Brands named

roxane laboratoriesroxane

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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