June 09, 2011

The Department of Health has ordered GlaxoSmithKline Limited to recall an antibiotic manufactured in France for paediatric patients, as a plasticiser has been detected in the product.
 
The product, Augmentin powder for syrup 156mg/5ml (HK-24658), was found to contain Diisodecyl phthalate (DIDP).
 
Augmentin is an antibiotic for the treatment of bacterial infections. In Hong Kong, there are two Augmentin products containing flavouring agents and both are for children. Samples were submitted to the Government Laboratory for plasticiser analysis.
 
The laboratory found DIDP in the French-made Augmentin powder for syrup 156mg/5ml at a level of 18ppm. This is two times Europe's specific migration limit for DIDP for food-contact materials. Plasticisers were not detected in the other samples tested.
 
DIDP's safety in humans is not well established. However, data on animal studies suggested that long-term consumption of DIDP at a high level may affect the liver.
 
No report of adverse events related to the product has been received, but GlaxoSmithKline Limited has failed to demonstrate the safety of the tainted product to the department's satisfaction. The threat to public health cannot be ruled out as this stage.
 
The department also said the issue of the selling of a drug not of the nature, substance or quality demanded by the purchaser could have been involved here, meaning the Public Health & Municipal Services Ordinance might have been contravened.
 
In view of the latest development in Taiwan's plasticiser incident, the department has stepped up its surveillance on pharmaceutical products containing flavouring agents.