Apotex has issued a voluntarily recall for one lot of fluticasone propionate nasal spray (lot NJ4501), which was shipped to wholesalers and distributors throughout the US and has an expiration date of July 2020. Apotex said that the FDA is aware of the recall and wholesalers and distributors have been notified.
According to the company, a consumer complaint resulted in discovery of small glass particles in the 50 μg per spray/120 dose product that could block the actuator and prevent the pump from working properly.
No adverse events have been reported, though the announcement noted that, “There is a potential for patients to be exposed to the glass particles and mechanical irritation cannot be ruled out. Local trauma to the nasal mucosa might occur with use of the defective product.
Read the Apotex press release.
