The Department of Health (DH) today (September 12) instructed Advance Pharmaceutical Co Limited (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 lists the quantity of 500mg for the ingredient paracetamol. The correct quantity should be 150mg of paracetamol.
Using the DH's surveillance network for manufactured drugs, Advance reported the mistake of listing the incorrect quantity of paracetamol after investigating a customer's enquiry.
"Each tablet of the product should contain 150mg of 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 of paracetamol per tablet," a DH spokesman said.
"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 explained.
"Duoflue Cold Tablet 1000's is indicated for the symptoms of cold and influenza. According to the records of Advance, a total of 267 of the affected bottles were distributed to private practitioners and pharmacies. So far, the DH has not received any related adverse incident report," the spokesman remarked.
"Labelling error is an offence under the Public Health and Municipal Services Ordinance (Cap 132). The maximum penalty is a fine of $50,000 and six months' imprisonment. The DH's investigation continues," the spokesman stated.
"Health-care 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 health-care providers. Advance has set up a hotline, 2497 0311, to answer related enquiries during office hours," the spokesman said.
Reprinted from HKSAR Government web page:
http://www.info.gov.hk/gia/general/201109/12/P201109120216.htm