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Recall of Omnaris Nasal Spray 50mcg due to quality defect (with photo)

     The Department of Health (DH) today (November 16) endorsed the voluntary recall of one batch (Batch number: 137930) of a pharmaceutical product called Omnaris Nasal Spray 50mcg (Omnaris) (Registration number: HK-59322) from shelves by a licensed drug wholesaler, Nycomed (Hong Kong) Limited (Nycomed), in view of a quality defect.

     The DH received notification from the company that the product's German manufacturer, Nycomed Gmbh, conducts a worldwide recall of affected batches as the manufacturer discovered pinhole or leakage in some of the pouches which might affect the product quality. According to the manufacturer, the defects in the pouches might lead to oxygen ingress to the pouch from ambient air and lead to a decrease of the preservative and an increase of its degradation product.

     Omnaris contains ciclesonide which is a steroid indicated for treatment of nasal symptoms associated with allergic rhinitis. It requires doctors' prescription and can only be sold in a pharmacy under the supervision of a pharmacist.

     The affected batch was manufactured in August 2010. A total of 9,807 boxes were imported and supplied to hospitals under the Hospital Authority (HA), private hospitals, private doctors, pharmacies and exported to Macao.

     According to the information from Nycomed so far, no batches manufactured since January 2011 showed pinhole defects of the pouches. DH's investigation continues.

     So far no adverse reports have been received.

     Nycomed has set up a hotline 2133 9800, operating from 9am to 5pm from Monday to Friday, to answer related enquiries.

     DH has already alerted the HA, private hospitals, professional healthcare bodies and the Macao authority about the matter and will closely monitor the recall.

     "Members of the public should check the pouches of the product before use. If they feel unwell, they should stop using the drug and consult their healthcare providers.

     "Here, contravention of Section 52(1) of the Public Health and Municipal Services Ordinance Cap 132, selling any drug not of the nature, substance or quality demanded by the purchaser, might have occurred. The maximum penalty involved is $10,000 and three months' imprisonment. On completion of our investigation, we will consult the Department of Justice for advice regarding prosecution," the spokesman said.

Ends/Wednesday, November 16, 2011
Issued at HKT 21:31


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