The United States: 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 (English Only)
 
The US Food and Drug Adminstration (FDA) announces that Apotex Corp. is voluntarily recalling one lot of Fluticasone Propionate Nasal Spray, USP, 50 mcg per spray, 120 Metered Sprays (lot number: NJ4501, expiration date: 07/2020), 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. 

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

Please refer to the following website in FDA for details: http://www.fda.gov/Safety/Recalls/ucm609436.htm 

In Hong Kong, Apo-Fluticasone Aqueous Nasal Spray 50mcg/dose (HK-60810) is a pharmaceutical product registered by Hind Wing Co Ltd (Hind Wing), and is a prescription-only medicine. As confirmed with Hind Wing, the affected batch has not been imported into Hong Kong. 

Ends/Friday, Jun 1, 2018 
Issued at HKT 15:00 

轉載自衛生署藥物辦公室網頁http://www.drugoffice.gov.hk/