The Department of Health (DH) today (November 11) endorsed a licensed drug manufacturer, Europharm Laboratoires Co Ltd (Europharm), to recall respectively two batches of Maxicold Tablets (HK-48879, batch numbers: B406178 and B412028) and Opticold Tablets (HK-48878, batch numbers: A406178 and A412028) from the market because the names and quantities of excipients used in these products do not match with the registered particulars.
Following the recall of six products by Europharm on November 6, DH's investigation further identified that the company has added two additives, namely hydroxypropyl cellulose and Croscarmellose sodium into the formulation of the above two products, without prior approval from the Pharmacy and Poisons Board. Hydroxypropyl cellulose and Croscarmellose sodium are common additives used in pharmaceutical products to facilitate binding of the ingredients and disintegration of the tablets respectively.
Investigation indicated that only the above-mentioned four batches of products were affected and considered as unregistered. Since the supply of unregistered pharmaceutical products contravenes the Pharmacy and Poisons Regulations (Cap 138A), Europharm voluntary recalls the products from the market. 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, both containing paracetamol and brompheniramine, are over-the-counter medicines used for the treatment of common cold symptoms. According to Europharm, the affected products have been supplied to 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.
Reprinted from HKSAR Government: http://www.info.gov.hk/gia/general/201511/11/P201511110858.htm