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 a labelling error.
The mistake came to light following 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 in the 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 records 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 the Hospital Authority and retailers while 120 boxes were exported to Macau.
Meanwhile, the DH has notified the Macau 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 at 2628 9775 to answer related enquires.
So far, the DH has not received any related adverse reports in connection with the product.
"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," the spokesman revealed.
"Health-care professionals and retailers must stop supplying, and customers must stop consuming, the said batch of the product immediately. For other batches, customers should check the product labelling before use. For those who have taken the affected product and are either in doubt or feeling unwell, they should consult their health-care providers," the spokesman urged.
(Reprinted from HKSAR Government web page
http://www.info.gov.hk/gia/general/201210/19/P201210190524.htm)