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Press Release

Recall of One Batch of Duoflue Cold Tablet 1000's

12 Sep 2011

The Department of Health (DH) today (September 12) instructs Advance Pharm Co. Ltd (Advance), a licensed drug manufacturer, to recall one batch (batch no.: 35262) of its product, Duoflue Cold Tablet 1000's (Registration No.: HK-37595) from the market because the new revised label wrongly printed the quantity of 500mg for the ingredient paracetamol. The correct quantity should be 150mg of the paracetamol.

Through DH's surveillance network of manufactured drugs, Advance reported the mistake of incorrect quantity of paracetamol after investigating into the enquiry of a customer.

"Each tablet of the product should contain 150mg paracetamol together with other active ingredients, namely salicylamide, phenylephrine, brompheniramine and caffeine. However, the label of the above batch of Duoflue Cold Tablet 1000's states that the product contains 500mg paracetamol per tablet," a DH spokesman says.

"The new label was recently revised to include the information on the potential liver toxicity of paracetamol as required by the Pharmacy and Poisons Board of Hong Kong. According to the available information at hand, only one batch was affixed with the revised wrong label," the spokesman explains.

"Duoflue Cold Tablet 1000's is indicated for the symptoms of cold and influenza. According to the record of Advance, a total of 267 of the affected bottles were distributed to private practitioners and pharmacies. So far, DH has not received any related adverse incident report," the spokesman remarks.

"Labelling error is an offence under the Public Health and Municipal Services Ordinance (Cap 132). The maximum penalty is a fine of HK$50,000 and six months' imprisonment. DH investigation continues," the spokesman states.

"Healthcare providers and retailers should stop supplying the product immediately. Those who have taken the affected product and are in doubt or feeling unwell should consult their healthcare providers. Advance has set up a hotline 2497 0311 to answer related enquiries during office hours," the spokesman urges.

The Department of Health today (September 12) instructed Advance Pharmaceutical Co Limited, a licensed drug manufacturer, to recall one batch (Batch No: 35262) of its product Duoflue Cold Tablet 1000's (Registration No: HK-37595) from the market because the new revised label shows a wrong quantity of 500mg for the ingredient paracetamol. The correct quantity should be 150mg of paracetamol.

12 September 2011