The Department of Health (DH) today (April 30) instructed a licensed drug wholesaler, 3 On Dental & Industrial Supplies Co, Ltd. (3 On), to recall from the market all flavours of Premier Topicale Topical Anesthetic Gel as they are unregistered pharmaceutical products in Hong Kong.
Upon the DH's investigation into a public complaint, the premises of 3 On were raided today and different flavours of the above product were seized. Hong Kong pharmaceutical product registration numbers were not found on the product labels. Preliminary investigation revealed that the products were imported into Hong Kong by 3 On and had been supplied to local dentists.
The above product, labelled as containing 18 per cent benzocaine, is used as a local anesthetic to be applied on the oral mucosa. Side-effects include dizziness, blurred vision, nausea and vomiting. They can only be sold in pharmacies under the supervision of registered pharmacists.
The DH's investigation is continuing.
3 On has set up a hotline (2522 8833 and 9285 4901) for public enquiries. The DH will closely monitor the recall.
According to the Pharmacy and Poisons Ordinance (Cap 138), all pharmaceutical products must be registered with the Pharmacy and Poisons Board of Hong Kong before they can be sold legally in the market. Illegal sale or possession of unregistered pharmaceutical products is a criminal offence. The maximum penalty for each offence is a fine of $100,000 and two years' imprisonment.
"All registered pharmaceutical products should carry a Hong Kong pharmaceutical product registration number on the package in the format of 'HK-XXXXX'," a spokesman for the DH remarked.
The DH will inform local dentists and relevant professional bodies to advise them not to use the products concerned because unregistered pharmaceutical products have not been evaluated by the Board and their safety, quality and efficacy may not be guaranteed.
Upon the DH's investigation into a public complaint, the premises of 3 On were raided today and different flavours of the above product were seized. Hong Kong pharmaceutical product registration numbers were not found on the product labels. Preliminary investigation revealed that the products were imported into Hong Kong by 3 On and had been supplied to local dentists.
The above product, labelled as containing 18 per cent benzocaine, is used as a local anesthetic to be applied on the oral mucosa. Side-effects include dizziness, blurred vision, nausea and vomiting. They can only be sold in pharmacies under the supervision of registered pharmacists.
The DH's investigation is continuing.
3 On has set up a hotline (2522 8833 and 9285 4901) for public enquiries. The DH will closely monitor the recall.
According to the Pharmacy and Poisons Ordinance (Cap 138), all pharmaceutical products must be registered with the Pharmacy and Poisons Board of Hong Kong before they can be sold legally in the market. Illegal sale or possession of unregistered pharmaceutical products is a criminal offence. The maximum penalty for each offence is a fine of $100,000 and two years' imprisonment.
"All registered pharmaceutical products should carry a Hong Kong pharmaceutical product registration number on the package in the format of 'HK-XXXXX'," a spokesman for the DH remarked.
The DH will inform local dentists and relevant professional bodies to advise them not to use the products concerned because unregistered pharmaceutical products have not been evaluated by the Board and their safety, quality and efficacy may not be guaranteed.
Reprinted from HKSAR Government:
http://www.info.gov.hk/gia/general/201404/30/P201404300872.htm