Sun Pharmaceutical Industries Inc, the U.S. arm of domestic drug major Pharmaceutical Industries Ltd., is recalling over 17,500 bottles of antihistamine Azelastine HCl nasal solution from the American market, latest enforcement report of the U.S. health regulator has said.
As per the enforcement report for the week of Feb. 21, of the U.S. Food and Drug Administration, Sun is recalling 17,554 bottles of Azelastine HCl Nasal Solution (nasal spray) 0.1 percent (137 micrograms per spray), 30 ml.
The nasal spray is indicated for the treatment of the symptoms of seasonal allergic rhinitis.
The bottles are being recalled, "following a failure to meet the % relative standard deviation requirement in the test for droplet size during the 6-month long-term stability test station," the U.S. FDA said.
The ongoing nationwide voluntary recall is a Class III recall, the report said.
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