Apotex yesterday issued a voluntary recall of one lot of fluticasone propionate allergy nasal spray devices, noting that they may contain small glass particles.
The company first discovered the issue thanks to a customer complaint. The glass particles could block the device’s actuator, according to Apotex, and impact the pump’s functionality.
The company’s sprays are used to treat seasonal and perennial allergic rhinitis, as well as sinus pain and pressure linked to allergic rhinitis in people ages four to 17.
“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. To date, Apotex Corp. has not received any reports of adverse events related to recall,” the company wrote in a notice posted to the FDA’s website.
The lot that Apotex recalled was identified as Lot No. NJ4501, set to expire in July 2020. The company said it has notified wholesalers and distributors via recall letter to arrange for the return of any recalled product.
“Consumers/wholesalers/retailers/hospitals/institutions with an existing inventory of the lot subject to this recall should stop use and distribution of the remaining units and quarantine immediately,” Apotex added.