There is a potential for patients to be exposed to the glass particles, as mechanical irritation and local trauma to the nasal mucosa could occur as a result of the problem, FDA said in a safety alert issued on Thursday.
The recalled nasal spray is 50 mcg per spray 120 metered sprays with the Lot #NJ4501.
Fluticasone Propionate is used to treat seasonal allergies, and for the management of sinus pain and pressure associated with allergies in patients 4 to 17 years of age. Brand names include Cutivate, Flonase Allergy Relief, and 24 Hour Allergy Relief.
The issue was discovered through a customer complaint, according to the FDA. Anyone concerned that the recalled Fluticasone Propionate may have affected them should consult their physician.
To date, Apotex Corp. has not received any reports of adverse events associated with the recall, FDA said.
Source: ABC 13