Glaxo Threatened With Legal Action By Hong Kong
July 19th, 2011 // 12:45 pm @ jmpickett
One month after finding traces of chemicals banned for use in food and drinks in the Augmentin pediatric antibiotic sold by GlaxoSmithKline, Hong Kong health officials are now threatening to take legal action against the drugmaker and widened a product recall to include not only powered syrups but also tablets.
Best Selling Webinar 2010 – July 21 2 PM – How to Write FDA-Compliant Quality Agreements
Speaker: Alan Minsk
The chemicals are known as phthalate esters, such as DIDP, and are generally used to make plastics more flexible, but a new government analysis found detectable levels in samples of the tablet version. And so the Hong Kong Department of Health says that, since Glaxo “could not provide satisfactory explanation on sources of the plasticisers, the quality of the product is in question.â€
Although the levels found are “unlikely to cause acute harmful effects if taken according to the recommended dosage,†health officials now say they will seek advice from the Department of Justice on possible legal actions against Glaxo, according to a statement.
Health officials previously indicated legal action may be pursued after claiming levels of the chemicals were much higher than what they say are permitted in Europe. Glaxo has denied this, however, and maintains levels are “significantly†lower than what is considered to prevent a risk according to US and European authorities (back story).
The issue has also created a stir in Taiwan, where hospitals last month suspended use of Augmentin and began investigating whether a strawberry-flavored version of the drug might have been contaminated by artificial flavoring, since jam makers were recently investigated for using materials containing banned chemicals as fixative agents to keep flavoring and fragrances smelling fresh.
Source: Pharmalot
