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Press Release

Recall of one batch of Nicorette Chewing Piece 4mg 105's

19 October 2012

The Department of Health (DH) today (October 19) endorsed Johnson & Johnson Consumer (Hong Kong) Limited (J&J), a licensed drug wholesaler, to recall one batch (batch no.: NL752C) of Nicorette Chewing Piece 4mg 105’s (Nicorette 4mg) (Registration No.: HK-25612) from consumers because of labelling error.

The mistake comes to light following a notification received from retailers.

"The promotional flag label of 2mg was wrongly affixed to the Nicorette 4mg batch by the local distributor Healthcare Division O/B LF Asia (HK) Ltd (LF Asia). This labelling error may result in an increase of occurrence of possible adverse effects e.g. nausea, vomiting and headache encountered by 2mg users who inadvertently used the 4mg gum" a DH spokesman remarked.

Nicorette 4mg is manufactured by McNeil AB in Sweden. It contains nicotine and is an over-the-counter drug used for smoking cessation.

J&J's sales record showed that 614 boxes of the affected batch were imported to Hong Kong in December 2011 and the promotional flag label of 2mg was affixed to the outer box of the product by the local distributor, LF Asia. This batch was then released to the market in July 2012. A total of 461 boxes were sold to Hospital Authority and retailers while 120 boxes were exported to Macau.

Meanwhile, DH has notified the Macao drug authority to take necessary action. It will also continue with the investigation as well as monitor the recall.

J&J has set up a hotline 2628 9775 to answer related enquires.

So far, DH has not received any related adverse reports in connection with the product.

"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 spokesman revealed.

"Healthcare professionals and retailers must stop supplying and customers stop consuming the said batch of the product immediately. For other batches, customers should check the product labeling before use. For those who have taken the affected product and are either in doubt or feeling unwell, they should consult their healthcare providers.," the spokesman urged.

Mislabelled Nicorette Chewing Piece 4mg 105's

19 October 2012