Hong Kong recalls antibiotic with plasticizer

08:48, June 10, 2011      

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Hong Kong Department of Health Thursday ordered GlaxoSmithKline Limited to recall an antibiotic manufactured in France for paediatric patients, as a plasticizer has been detected in the product.

The product involved is Augmentin powder for syrup 156mg/5ml (HK-24658) which was made in France. It was found by the local government laboratory to contain Diisodecyl phthalate (DIDP) at a level of 18ppm, which is two times Europe's specific migration limit for DIDP for food-contact materials.

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 by the department.

The department 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 and Municipal Services Ordinance might have been contravened.

In view of the latest development in Taiwan's plasticizer incident, the department has stepped up its surveillance on pharmaceutical products containing flavoring agents.

Source: Xinhua
 
 
     
 
 
 
     
 
 
 
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