Contaminated drug ingredient found in GSK facility in Ireland

04/2/2014 | Reuters

Contaminated paroxetine, a drug ingredient used to make antidepressant drugs Seroxat and Paxil, was discovered by the FDA at a GlaxoSmithKline facility in Ireland. GSK did not take enough action to resolve the plant's objectionable conditions that were listed by regulators after an October inspection, the FDA said in a March 18 letter. GSK also failed to notify customers about the problem after shipping batches of a drug or drugs with the contaminated ingredient, the agency added. The FDA said that unless the issues are resolved, approval of new-drug applications listing GSK as producer of drug ingredients might be denied and import of drugs produced from the facility might be blocked.

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