Apotex Corp. Issues Voluntary Nationwide Recall of Fluticasone Propionate Nasal Spray USP 50 mcg Per Spray 120 Metered Sprays Due to Potential for Small Glass Particles (2024)

Summary

Company Announcement

Apotex Corp. is voluntarily recalling one (1) lot of Fluticasone Propionate Nasal Spray, USP, 50 mcg per spray, 120 Metered Sprays, to the consumer level. The Fluticasone Propionate Nasal Spray USP 50 mcg per spray 120 Metered Sprays has been found to contain small glass particles. The glass particles could block the actuator and impact the functionality of the pump. The issue was discovered through a customer complaint.

Risk Statement: 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.
Fluticasone Propionate Nasal Spray USP 50 mcg per spray 120 Metered Sprays 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 The affected Fluticasone Propionate Nasal Spray USP 50 mcg per spray 120 Metered Sprays can be identified by the information in the table below: and on the product label:

The affected Fluticasone Propionate Nasal Spray, USP, 50 mcg per spray, 120 Metered Sprays was distributed nationwide to wholesalers and distributors.

Apotex Corp. has notified wholesalers/distributor by recall letter to arrange for 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. Healthcare Professionals in your organization should be informed of this recall. If you have further distributed the recalled product, to the wholesale or retail level, please notify any accounts or additional locations which may have received the recalled product from you. 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 physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report Online: www.fda.gov/medwatch/report.htm
• Regular Mail or Fax: download form www.fda.gov/MedWatch/getforms.htm or call 1-800-FDA-1088 to request form, then complete and return address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.