Ingredient at GSK in Carrigaline contaminated with waste
Ingredients manufactured in a Cork Pharmaceutical company have been found to be contaminated by its waste tank. It has been reported that GlaxoSmithKline became aware of the contamination as far back as January 2012. The US Drug and Food Administration said the contamination of the ingredient effects anti-depressant drugs branded Paxil and Seroxat. The pharmaceutical company's Carrigaline carried out risk assessments to determine the impact on its products. However the potentially contaminated drugs had already been distributed at this point. The FDA told the company of the possibility of withholding any approval of new applications or supplements listing GSK a manufacturer, until 'deviations' were corrected. GSK issued a recall notice of 47 batches affected dating from March 2011 to February 2012 around the globe. It is not known if any batches were in circulation in Ireland however the company says after a full assessment they have determined there is no risk to human health.
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