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Recall of an unregistered poison cum pharmaceutical product (with photo)

     The Department of Health (DH) today (February 21) instructed Coloplast (Hong Kong) Limited (Coloplast) to recall its Biatain Ibu dressing from shelves as the product contains Ibuprofen, a poison and a pharmaceutical product with both anti-inflammatory and analgesic functions.

     A DH spokesman revealed that the matter came to light as the Department processed an enquiry about the product.

     "Biatain Ibu dressing actually contains 0.5 mg ibuprofen per cm². It is for use on exuding wounds, for promoting wound healing and reducing pain caused by tissue damage," the spokesman elaborated.

     "After assessment, DH is of the opinion that the product manufactured in Denmark is in fact a poison and a pharmaceutical product. As such, it must be registered with the Pharmacy and Poisons Board, requires a licence for import and wholesale, and can only be sold under the supervision of a pharmacist," the spokesman remarked.

     Coloplast is not a holder of a wholesale poison licence nor a licensed drug importer, but its sales record does show that it has been importing the product into Hong Kong since August 2011 for distribution to the hospitals and clinics of the Hospital Authority and some private hospitals.

     "As the efficacy, safety and quality of unregistered drugs cannot be guaranteed, we opt that a recall is indicated though we have not received any report of related adverse event thus far," the spokesman stressed.

     Ibuprofen can also be administered orally besides topical application. Common side effects include gastrointestinal discomfort, headache and dizziness.

     "Here, contravention of the Pharmacy and Poisons Ordinance and Import and Export Ordinance are suspected. The sale of unregistered pharmaceutical products and the sale of Part I poison are both offences under the Pharmacy and Poisons Ordinance. The maximum penalty is a fine of $100,000 and two years' imprisonment for each offence. Separately, the import of a pharmaceutical product without licence is an offence under the Import and Export Ordinance. The maximum penalty is a fine of $500,000 and two years' imprisonment," the spokesman said.

     Coloplast has set up a hotline 3628 7436 for public enquires. DH will monitor the recall.

     "Healthcare professionals must stop supplying the product and hand it over to the department's Drug Office at 3/F, Public Health Laboratory Centre, 382 Nam Cheong Street, Kowloon, during office hours for disposal. For those who have used the affected products and are either in doubt or feeling unwell, they should consult their healthcare providers," the spokesman urged.

Ends/Tuesday, February 21, 2012
Issued at HKT 20:16


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