21 Apr 2009
The Department of Health (DH) today (April 21) instructed Deltapharm Ltd, a licensed pharmaceutical wholesaler, to recall from the retail a pharmaceutical product, Funginox Solution 2% (HK-47148), with unregistered indications and treatment duration on the packaging insert.
A DH spokesman said the product was imported from Thailand and used for treatment of a fungal infection of foot commonly known as athlete's foot.
Following a routine inspection of the company yesterday, DH today found that the packaging insert of the product contained indications for treatment other than athlete's foot and recommended treatment duration of 2 to 4 weeks which was yet to be substantiated.
The spokesman said under the Pharmacy and Poisons Ordinance, a pharmaceutical product was regarded as registration drug only if the particulars of the product including its package information, corresponded exactly with its registered particulars.
Any change of the registrable particulars must be approved by the Pharmacy and Poisons Board, he said.
Although there was no immediate safety and quality concern with the use of the product, members of the public should stop using the product and seek advice from healthcare professionals as appropriate.
The product was supplied to private doctors and pharmacies and was sold under the supervision of a registered pharmacist.
Doctors and pharmacists are reminded to stop administering or supplying the product to their clients.
The company has set up a hotline (31136103) to answer clients' enquiries.
DH's investigation is on-going.
The spokesman said sale of unregistered pharmaceutical product was an offence under the Pharmacy and Poison Ordinance. Upon conviction, the maximum penalty is a fine of HK$100,000 and 2 years' imprisonment.