BEIJING - The State Food and Drug Administration (SFDA) has ordered leading healthcare company GlaxoSmithKline Plc. (GSK) to recall an antibiotic product laced with a plasticizer.
According to a notice released Saturday on its official website, the SFDA said that test results show that GSK's amoxicillin and clavulanate potassium for suspension contains traces of Di-isodecyl phthalate (DIDP), which is mainly used as an additive in plastics to make them more flexible.
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.
In the notice, the SFDA ordered the immediate halt of the selling and use of the product, and those that had already entered the Chinese market must be recalled.
Earlier this month, Taiwan and Hong Kong ordered the UK-based pharmaceutical giant to recall two pediatric Augmentin medications that were also found to contain DIDP.
Augmentin is primarily used to treat bacterial infections such as ear infections, sinusitis, pneumonia, bronchitis and urinary tract infections.