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Friday, June 10, 2011

Glaxo's Augmentin for Paediatric Patients Recalled

The Hong Kong Department of Health announced yesterday that they had ordered GlaxoSmithKline to recall an antibiotic manufactured in France for paediatric patients.

Augmentin powder for syrup, used to treat many different infections caused by bacteria, such as sinusitis, pneumonia, ear infections, bronchitis, urinary tract infections, and infections of the skin, was found to have traces of a plasticiser, Diisodecyl phthalate (DIDP) in the 156mg/5ml bottles.

Diisodecyl phthalate (DIDP) is a commonly used plasticizer used in the production of plastic and plastic coating to increase flexibility. It is a mixture of compounds derived from the esterification of phthalic acid and isomeric decyl alcohols.

The coating on furnishings, cookware, pharmaceutical pills, food wrappers and many other products may have DIDP or other phthalates in them. There has been recent concern in the USA and European Union for their toxicity and bioaccumulative quality. [1]

7th Space Interactive writes:

Referring to the detection of plasticiser in Augmentin in Taiwan in particular, the spokesman explained, "Augmentin is an antibiotic for the treatment of bacterial infections. In Hong Kong, there are two Augmentin products containing flavouring agents, both of which are registered under GSK by the Pharmacy and Poisons Board, namely Augmentin powder for syrup 156mg/5ml manufactured in France, and Augmentin powder for syrup 457mg/5ml manufactured in the UK. Both are for use in children.

Samples were submitted earlier on to the Government Laboratory (GL) for plasticiser analysis."

The spokesman went on to reveal that, "On testing, the GL found DIDP in the French-made Augmentin powder for syrup 156mg/5ml at a level of 18ppm. This is two times Europe's specific migration limit for DIDP for food contact materials. Plasticisers were not otherwise detected in the other samples tested."

Well, whaddya know - Glaxo and children's medicine in the news [again]

The Hong Kong Standard also reports on Glaxo's product recall, they write:

A British pharmaceutical firm faces possible prosecution in Hong Kong after tests showed a pediatric syrup manufactured in its French factory contained twice the allowable limit for a plasticizer.

...The Augmentin powder for syrup 457/5ml manufactured in Britain did not have any trace of DIDP. Both contained flavoring agents, suspected to be the main source of contamination.

The department has already notified the Drug Regulatory Authority in France.

"The source of DIDP is yet to be investigated by the manufacturers," a spokeswoman said.

About 400 children treated at Hospital Authority clinics and hospitals have been prescribed the drug and still have it on hand.

GlaxoSmithKline's corporate motto is that it helps people to...


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