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Drug still on the market despite order for recall

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Amy Nip

An antibiotic containing a toxic chemical two times above the European safety limit for food was still on the market yesterday - a day after the government ordered its recall - as a different batch of the antibiotic was ordered recalled.

A spokeswoman for GlaxoSmithKline, the maker of the drug Augmentin, said a timetable and arrangements for the recall would be set after discussions with the government.

Health chief Dr York Chow Yat-ngok said the government could deregister the drug if the company did not recall it.

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The 156mg/5ml version of Augmentin syrup, made by GSK in France and commonly prescribed to children, was found to contain 18 parts per million of diisodecyl phthalate (DIDP), one of a group of chemicals known as plasticisers, commonly used to make hard substances more malleable. There is no set safety level for DIDP in pharmaceutical products, but the European Union limit for food products is 9ppm.

The manufacturer said on Thursday that the DIDP content identified in the sample tested by the government was significantly lower than the levels that the US and European authorities 'deem to present a level of risk'. 'With that in mind, GSK continues to support the safe use of the product as prescribed by a doctor or health provider,' it said.

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Yesterday, the company said it was seeking to clarify with the government what safety standards it would have to follow to keep selling the drug.

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