Sun Pharmaceutical Industries’ US arm - Sun Pharmaceutical Industries Inc (collectively Sun Pharma) is recalling over 17.5 thousand bottles of antihistamine Azelastine HCI nasal solution from the US market. The company is recalling 17,554 bottles of Azelastine HCI Nasal Solution (Nasal Spray) 0.1 per cent (137 mcg per spray), 30 ml indicated for the treatment of the symptoms of seasonal allergic rhinitis.
The ongoing nationwide voluntary recall is a class III recall and is 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.
Sun Pharmaceutical Industries is the world’s fourth largest specialty generic pharmaceutical company and India’s top pharmaceutical company.
