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news.China's top drug authority the State Food and Drug Administration (SFDA) has ordered GlaxoSmithKline (GSK) to withdraw Augmentin antibiotic syrup (amoxicillin and clavulanate potassium for suspension), following reports that it contains traces of Di-isodecyl phthalate (DIDP), an additive used to make plastics more flexible.
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The drug is indicated to treat a variety of infections in adults and children, in particular.
With this move, China has become the latest Asia-Pacific nation, after Hong Kong and Taiwan, to withdraw the drug over safety concerns.
The SFDA has also ordered to stop selling and using the antibiotic and told local drug authorities to enhance their supervision and inspection.
Telegraph.co.uk has quoted GSK’s spokesman as saying that the company is currently in discussion with a number of regulatory agencies in the Asia Pacific region, some of whom have also conducted tests.
"The amount of phthalates identified as present in Augmentin syrup samples tested is very low; some tests have found none and the highest level reported by the authorities is 88 parts per million. Even this highest result is significantly lower than the levels that the US and European authorities deem as presenting no risk to humans," he said.
Chinadaily.com has quoted GSK Corporate Communications and Public Relations Department director Zhang Saying as saying that the amount of the chemical identified at present in the product samples tested was very low.
"It is significantly lower than the levels that the US and European authorities deem as presenting no level of risk to humans. But GSK is conducting a thorough investigation into the situation and will be in compliance with the SFDA decision to recall all of the medicines on the mainland," Saying said.
"We can confirm that we do not intentionally use DIDP as an ingredient in Augmentin Syrup. The only source of the chemical currently identifiable is the plastic lining inside the bottle cap and further investigation is under way," reported the website.