Apotex Corp. is recalling an allergy nasal spray after a customer complained about finding bits of glass in a bottle of the medication. The glass particles could block the actuator and impact the pump. But even more disturbing is the risk that some users may inadvertently spray the glass up their noses.
“Mechanical irritation cannot be ruled out,” the company said in a news release. “Local trauma to the nasal mucosa might occur with use of the defective product.” To date, Apotex Corp. has not received any repots of adverse events related to this issue.
The recall affects lot # NJ4501 of Fluticasone Propionate Nasal Spray, USP, 50 mcg per spray, 120 metered sprays. The medication is indicated for the treatment of seasonal and perennial allergic rhinitis and for the management of sinus pain and pressure associated with allergic rhinitis in patients age 4 to 17. The affected nose spray has the NDC 60505-0829-1, and the expiration date of 7/2020.
Apotex Corp. has notified its wholesalers and distributors by letter to return any recalled product. Consumers and medical facilities with affected nasal sprays should stop use and quarantine the medication immediately.
Customers should contact their physician or health care provider if they have experienced any problems that may be related to taking or using this drug product. Any adverse events related to this recall should be reported to the Food and Drug Administration (FDA) MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.
Source: FDA Recall Notice