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GSK Cork ingredient polluted with waste
Active pharmaceutical ingredients manufactured by GlaxoSmithKline in Cork have been found to be contaminated from its pharmaceutical waste tank.
The US Food and Drug Administration said the company became aware of the contamination of the ingredient, which is in anti-depressant drugs that go by brand names Paxil and Seroxat, at its plant in Currabinny, Carrigaline, as far back as January 2012.
It said GSK completed risk assessments to determine the impact on its products, but said potentially contaminated batches were distributed after it became aware of the “significant deviation”.
The FDA told GSK: “Until all corrections have been completed and FDA has confirmed corrections of the deviations and your firm’s compliance with current good manufacturing practice, FDA may withhold approval of any new applications or supplements listing your firm as an [active pharmaceutical ingredients] manufacturer.”
The FDA said failure to correct the deviations could result in the FDA refusing admission of “articles” manufactured at the company.
GSK has issued a recall for 47 batches affected, dating from March 2011 to February 2012. It said regulatory bodies in countries where the batches ended up will issue the recalls. A company spokeswoman in Ireland was unable to confirm whether any of the batches went into circulation here.
GSK last night said it had carried out a full assessment and determined there was no risk to human health.