China’s drug regulator ordered a recall over the weekend of an antibiotic manufactured by UK-based pharmaceutical company GlaxoSmithKline (GSK.LON) that had been shown to contain traces of a banned plasticizer, state media reported. Tests showed that amoxicillin and clavulante potassium produced by GSK contained traces of Di-isodecyl phthalate, used to make plastics more flexible, according to an announcement issued online by the State Food and Drug Administration on Saturday. The administration urged local drug authorities to enhance their supervision and inspection, as public concern about plasticizer-tainted products builds. Animal tests indicate that long-term consumption of DIDP at high levels can affect the liver, although its impact on humans is not well established. Zhang Saying, director of corporate communications and public relations at GSK, confirmed that the products being recalled on the mainland are the same ones that caused public concern in Hong Kong and Taiwan earlier this month. Zhang said that the amount of the chemical identified in product samples 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,” Zhang said.
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