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FDA finds contaminated drugs at pharma plant

By Tim Sandle     Apr 4, 2014 in Health
The FDA has found that a drug ingredient manufactured at a GlaxoSmithKline Plc plant in Ireland was contaminated and says the company did not take sufficient action to resolve the problems.
The report from the U.S. Food and Drug Administration (FDA) states that GSK did not fully investigate a list of objectionable conditions the regulator sent after its inspection of the plant at Cork in October.
The ingredient was paroxetine, used to make its antidepressant drugs Paxil and Seroxat. Paroxetine is an antidepressant drug. Paroxetine is used to treat major depression, obsessive-compulsive disorder, panic disorder, social anxiety, posttraumatic stress disorder, generalized anxiety disorder and vasomotor symptoms (e.g. hot flashes and night sweats) associated with menopause.
As a result, Fierce Pharam reports, GSK had proposed a recall of certain batches of the drugs from wholesalers; however, upon review, the company decided that there was no risk of harm to patients taking these drugs.
The problem was that some batches of a drug or drugs using the contaminated ingredient were later shipped and GSK did not notify its customers about the lapse. The FDA says its investigator found that a certain drug ingredient was contaminated with material from the plant's pharmaceutical waste tank.
The FDA has indicated that it might refuse the import of drugs manufactured at the Cork facility into the U.S.
More about Fda, Drugs, Pharma, Contamination, adulteration
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