Sun Pharmaceutical Industries Inc, the US arm of domestic drug major Sun Pharma, is recalling over 17,500 thousand bottles of antihistamine Azelastine HCl nasal solution from the American market, latest enforcement report of the US health regulator has said.
As per the enforcement report for week of February 21, 2017 of the USFDA, Sun Pharmaceutical Industries Inc is recalling 17,554 bottles of Azelastine HCl Nasal Solution (Nasal Spray) 0.1 per cent (137 mcg 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 % RSD requirement in the test for Droplet Size during the 6 month long term stability test station," the United States Food and Drug Administration (USFDA) said.
The ongoing nationwide voluntary recall is a class III recall, the report said.
As per USFDA, a class III recall is initiated in a situation "in which use of, or exposure to, a violative product is not likely to cause adverse health consequences".