The Department of Health (DH) today (May 3) instructed a licensed drug wholesaler, Henry Schein Hong Kong Holdings Limited, to recall from the market all flavours of Benzo-Jel Topical Anesthetic Gel as they are unregistered pharmaceutical products in Hong Kong.
Upon the investigation of a public complaint, the premises of Henry Schein were raided today and a quantity of different flavours of Benzo-Jel Topical Anesthetic Gel was 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 Henry Schein and were supplied to local dentists.
Benzo-Jel Topical Anesthetic Gel, labelled as containing 20 per cent benzocaine, is used as a local anaesthetic 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.
Henry Schein has set up a hotline on 3650 7668 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 registration number on the package in the format of 'HK-XXXXX', a DH spokesman remarked.
The DH will inform 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 investigation of a public complaint, the premises of Henry Schein were raided today and a quantity of different flavours of Benzo-Jel Topical Anesthetic Gel was 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 Henry Schein and were supplied to local dentists.
Benzo-Jel Topical Anesthetic Gel, labelled as containing 20 per cent benzocaine, is used as a local anaesthetic 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.
Henry Schein has set up a hotline on 3650 7668 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 registration number on the package in the format of 'HK-XXXXX', a DH spokesman remarked.
The DH will inform 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/201305/03/P201305030513.htm