WASHINGTON, D.C. — Apotex Corp., the maker of Fluticasone Propionate nasal spray, is recalling 50 mcg per spray 120 meterd spray products with the Lot #NJ4501 due to small glass particles found in some of the bottles, according to the Food & Drug Administration.
The glass particles could block the actuator and impact the functionality of the pump, the FDA says. There is also potential for users to be exposed to the glass particles, and mechanical irritation cannot be ruled out.
The issue was discovered through a customer complaint, the FDA says. There have been no reports of adverse events related to the recall.
Fluticasone Propionate Nasal Spray 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 4 to 17 years of age. It is commonly sold under brand names like Cutivate, Flonase Allergy Relief, 24 Hour Allergy Relief.
Patients, wholesalers, retailers, hospitals or institutions with Lot# NJ4501 and an expiration date of July 2020, should stop use and distribution of the remaining units and quarantine immediately. For additional assistance, call GENCO Pharmaceutical Services, a subsidiary of FedEx Supply Chain (GENCO) at 1- 877-475-5863 (7:00am – 5:00pm, CST Monday thru Friday), to arrange for return of the product.
Customers with questions regarding this recall can contact Apotex Corp. by phone-number 1-800-706-5575 (8:30am – 5:00pm, EST Monday thru Friday) or email address UScustomerservice@Apotex.com.
Customers should contact their healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
