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The Department of Health (DH) today (November 6) endorsed a licensed drug manufacturer, Europharm Laboratoires Co Ltd, to recall six products from the market because the names and quantities of excipients used in these products do not match with the registered particulars. The six products are Euro-Antinal Capsules 200mg (HK-41562), Naswall Capsules 200mg (HK-54739), Bovill Capsules 200mg (HK-54740), Melitte Capsules 200mg (HK-54741), Davicoff Capsules (HK-54742) and Sinpress Capsules 200mg (HK-54743).
Acting on a complaint, investigation has been carried out against Europharm and it was found that the company has added an additive, namely hydroxypropyl cellulose, into the formulation of the above six products. Hydroxypropyl cellulose is a common additive used in pharmaceutical products to facilitate binding of the ingredients. However, such changes in the formulation have not been approved by the Pharmacy and Poisons Board and render the products unregistered. Since the supply of unregistered pharmaceutical products contravenes the Pharmacy and Poisons Regulations (Cap 138A), Europharm has voluntarily recalled the products from the market. The DH's investigation is continuing.
According to the Pharmacy and Poisons Regulations, illegal sale of unregistered pharmaceutical products is an offence and the maximum penalty upon conviction is a fine of $100,000 and two years' imprisonment.
The above-mentioned products, all containing Nifuroxazide, are over-the-counter medicines used for the treatment of diarrhoea. According to Europharm, the affected products have been supplied to private doctors, local pharmacies and medicine companies.
So far, the DH has not received any adverse reports in connection with the products concerned.
Europharm has set up a hotline (2666 3392) to answer related enquiries. The DH will closely monitor the recall.
Ends/Friday, November 6, 2015
Issued at HKT 20:27
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