Fluticasone Propionate Nasal Spray USP 50 mcg per spray 120 Metered Sprays is used to treat seasonal allergic rhinitis and perennial allergic rhinitis. It is also perscribed for managing sinus pain and sinus pressure – the kind associated with allergic rhinitis for patients of certain ages.
Apotex Corp., a company that produces Fluticasone Proprionate Nasal Spray, issued a voluntary recall of Fluticasone Propionate Nasal Spray USP 50 mcg Per Spray 120 Metered Sprays . The reason was potential for small glass particles.
The company is recalling one lot of the product that has reached the consumer level. The particular lot of the Nasal Spray was found to contain small glass particles that were blocking the actuator and impacting the function of the spray pump. The issue was discovered after a customer complained.
Always complain if you buy a pharmaceutical product and it doesn’t work the way it it supposed to, even if the flaw seems to be merely technical. The entire lot of it may be faulty and you may be helping many people by alerting the company to the problem.
There is also potential risk that patients using the product would be exposed to the glass particles-i.e., spray them up their noses. That would cause local trauma to the nasal mucosa, or “mechanical irritation” that may cause worse nose problems than the patient had before. Imagine what a particle of glass could do if it got stuck in the sinuses or the nasal passages.
To date, Apotex Corp. hasn’t gotten any reports of adverse effects related to this problematic lot of Fluticasone Propionate Nasal Spray USP 50 mcg Per Spray 120 Metered Sprays . The affected lot of Fluticasone Propionate Nasal Spray, USP, 50 mcg per spray, 120 Metered Sprays was distributed nationwide to wholesalers and distributors. Apotex Corp. notified wholesalers and distributor by letter to arrange for return of any recalled product
What To Do:
If you are a consumer with an inventory of the lot subject to this recall, stop using or distributing the units remaining in your possession and put them aside immediately. Notify your Doctor or Healthcare Professional about this recall if you’re reading this and think they may be distributing this product. Notify anyone that has bought or received this product from you about the recall.
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:
1-800-706-5575 (8:30am – 5:00pm, EST Monday thru Friday)
or email address UScustomerservice@Apotex.com.
Contact your physician immediately if you have experienced any problems that may be related to taking or using this drug product.
You can report adverse reactions or quality problems 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.
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