Sunday, June 19, 2011

中國SFDA要求GSK 受塑化劑污染 Augmentin 下架!!

China orders GSK to recall antibiotic  SHANGHAI, June 18 | Sat Jun 18, 2011 (Reuters) - China has ordered GlaxoSmithKline (GSK) to recall an antibiotic product which has been found to be laced with a plasticiser, raising safety and quality concerns. The State Food and Drug Administration (SFDA) said in a statement on Saturday said that test results showed that GSK's amoxicillin and clavulanate potassium contained traces of Di-isodecyl phthalate (DIDP), mainly used as an additive in plastics to make them more flexible. The SFDA has ordered the immediate halt of the sale and use of the product. Earlier this month, Taiwan and Hong Kong ordered the UK-based pharmaceutical giant to recall its paediatric antibiotic medication, Augmentin, after it was found to contain DIDP. DIDP's safety for human consumption was not well established, but data from animal studies suggested long-term consumption of high levels of DIDP may affect the liver. Amoxicillin and clavulanate potassium is a combination medicine that is used for treating a variety of infections in adults and children.

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