FDA finds contaminated drugs at GlaxoSmithKline’s plant in Ireland

DUBLIN, IRELAND: The US Food and Drug Administration found that a drug ingredient manufactured at a GlaxoSmithKline Plc plant in Ireland was contaminated and said the company did not take sufficient action to resolve the problems. GSK said the ingredient was paroxetine, used to make its antidepressant drugs Paxil and Seroxat. The company said it had proposed a recall of certain batches of the drugs from wholesalers but there was no risk of harm to patients taking these drugs.

In a warning letter dated 18 March 2014, the FDA said GSK did not fully investigate a list of objectionable conditions the regulator sent after its inspection of the plant at Cork in October. Some batches of a drug or drugs using the contaminated ingredient were later shipped, the FDA said, and GSK did not notify its customers about the lapse.

The FDA said its investigator found that a certain drug ingredient was contaminated with material from the plant’s pharmaceutical waste tank. The FDA said it might with hold approval of any new drug applications that list GSK as the manufacturer of their drug ingredients until GSK corrected the issues. The regulator said it also might refuse the import of drugs manufactured at the Cork facility (in Ireland) into the United States.

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