Hong Kong orders recall of Glaxo antibiotic

Monday, September 5, 2011 // by Michael David S. Peñacerrada // Labels: // 0 comments

HONG KONG — Hong Kong has ordered pharmaceutical giant GlaxoSmithKline to recall an antibiotic which contained chemical additives, and warned it may take legal action against the manufacturer.
The health department said tests revealed the British-based firm's Augmentin antibiotic tablet contained several plasticisers, including diisodecyl phthalate (DIDP), raising "quality concerns."
Last month, the health watchdog also ordered a recall of the antibiotic in syrup form -- usually used for children -- over elevated levels of DIDP, warning that long-term consumption at high levels could harm the liver.
But the department said Tuesday the amount of the chemicals -- used to make plastics pliable -- uncovered in the Augmentin tablets was "considered unlikely to cause acute harmful effects if taken according to the recommended dosage."
The health department said in a statement late Monday it would "seek Department of Justice's advice on possible legal actions against (GlaxoSmithKline)" but did not elaborate.
"Since GSK could not provide satisfactory explanation on sources of the plasticisers, the quality of the product is in question," it said.
In a statement Tuesday, the drug firm said it had launched an "urgent and thorough investigation" to determine the source of the additives.
"GSK does not intentionally use any plasticisers in the manufacture of Augmentin," it said, adding they were "significantly lower than the levels that the US and European authorities deem as presenting risk to humans."
China, South Korea, the Philippines and Hong Kong earlier this year banned imports of certain food and drinks from Taiwan after some were found to contain plasticisers, which experts say can cause hormone problems in young people.
Taiwan prosecutors said last month they were seeking long jail terms for four people on charges of selling the banned chemicals to food makers, triggering the island's worst food scare in decades.

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