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Press Release

Batch recall of Fensinemix cough syrup

18 February 2013

The Department of Health (DH) today (February 18) instructed a licensed drug manufacturer, Loyal Advance Limited, to recall one batch (AAC18B) of Fensinemix cough syrup (registration number: HK-38911) from shelves due to a labelling error.

Upon investigation of a public enquiry, the DH found that some bottles, but not the outer boxes, of the batch (AAC18B) of Fensinemix cough syrup were wrongly labelled as Ammocol cough syrup (registration number: HK-43200). This error only appears on some bottle labels.

Fensinemix cough syrup is an over-the-counter medicine containing chlorpheniramine, noscapine and guaiphenesin indicated for the relief of cough. On the other hand, Ammocol cough syrup contains codeine and ephedrine that can only be sold at a pharmacy under the supervision of a registered pharmacist.

The DH's investigation is continuing. Loyal Advance has voluntarily suspended its production to facilitate the DH's investigation.

"Labelling errors are 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," a DH spokesman said.

So far, the DH has not received any adverse reaction reports related to the product.

According to the information available so far, about 400 bottles of the affected batch of Fensinemix cough syrup had been supplied to local pharmacies and medicine stores since October 2012.

Loyal Advance has set up a hotline (2433 6608) to answer public enquiries. The DH will closely monitor the recall.

"Those who have used the product should consult their health-care providers if in doubt or feeling unwell," the spokesman said.

The Department of Health today (February 18) instructed a licensed drug manufacturer, Loyal Advance Limited, to recall one batch (AAC18B) of Fensinemix cough syrup (registration number: HK-38911) from shelves due to a labelling error.

18 Feb 2013