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The Department of Health (DH) today (August 11) endorsed the proposal of GlaxoSmithKline Ltd (GSK), a licensed drug wholesaler, to recall one batch (batch no.: XPN161R) of its product, Coldrex+C Tablet 20's (Registration No.: HK-50258) from consumers as the batch's dosage instruction in Chinese has an error.
"The mistake comes to light following the GSK routine in-house check.
"The dosage of a tablet every four to six hours as required for children aged 6 and above as appears in the original English insert and unit carton is correct. However, the insert in Chinese, worded as two tablets every four to six hours as required, has somehow doubled the recommended dosage," a DH spokesman remarked.
Coldrex+C Tablet 20's contains paracetamol, phenylephrine, terpin hydrate, caffeine and ascorbic acid as ingredients and is an over-the-counter drug used to relieve cold and flu symptoms in both adults and children aged 6 and above.
GSK's sales record showed that it imported the affected batch of 20-tablet packs from Ireland. 1,398 packs were then distributed by L F Asia (Hong Kong) Ltd (L F), another licensed drug wholesaler, for sale here, while 240 packs were re-exported to Macao.
"DH staff inspected L F's premises today. It is found that before distribution, L F was responsible to include a paracetamol package warning label and an insert in Chinese. Somehow, a printing error occurred in the Chinese insert which has skipped notice," the spokesman explained.
"That only one batch is likely to be involved because it was the only one distributed since the introduction of the new paracetamol package warning label since this July," the spokesman deliberated.
"Given that overdose of paracetamol is known to be associated with serious health consequences such as liver injury and gastrointestinal discomfort, with children being particularly vulnerable, we agree it necessary for GSK to recall the batch though DH has not received any related adverse incident report so far," the spokesman stated.
"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 those who have taken the affected product and are either in doubt or feeling unwell, they should consult their healthcare providers. GSK has set up a hotline 3189 8765 to answer related enquiries," the spokesman urged.
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.
Ends/Thursday, August 11, 2011
Issued at HKT 21:08
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