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  4. 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
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COMPANY ANNOUNCEMENT

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

When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.

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Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Drugs
Generic Drugs
Reason for Announcement:
Recall Reason Description
Small Glass Particles
Company Name:
Apotex Corp.
Brand Name:
Brand Name(s)
Apotex
Product Description:
Product Description
Fluticasone Propionate Nasal Spray

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:

NDC Lot
Number
Expiration
Date
Strength Configuration/Count
60505-0829-1 NJ4501 07/2020 50 mcg per
spray
120 Metered
Sprays
Carton containing 1 Bottle of 50
mcg per spray 120 Metered Sprays

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. 


Company Contact Information

Consumers:
1-800-706-5575
UScustomerservice@Apotex.com
Media:
Jordan Berman, Global Director, Corporate Communication
1 (416)749-9026 Ext. 7487
jberman@apotex.com

Product Photos