Adulterated (Contaminated) Seroxat Recalled by FDA


Wednesday, May 28, 2014

SEVERAL batches of anti-depression medicine, paroxetine (seroxat), have been voluntarily recalled after they were found to have been “adulterated.”

According to the Food and Drug Administration (FDA), GlaxoSmithKline (GSK) Philippines Inc. is implementing a voluntary recall of paroxetine 20 milligram tablet (Seroxat) with batch numbers 601, 602M, and 603.

“Non-compliance to current good manufacturing practice (cGMP) had resulted in the voluntary recall of specific batches of paroxetine 20 mg tablet (seroxat),” said FDA Advisory 2014-038.

The FDA said the voluntary recall comes after a warning letter was sent by the US FDA to GSK USA concerning “critical deviations” made by the latter’s active pharmaceutical ingredients (API) manufacturer, SmithKline Beecham (Cork) Ltd. at Currabinny Carriagaline Cork, Ireland.

“SmithKline Beecham (Cork) Ltd. at Currabinny Carriagaline Cork, Ireland had critical deviations which caused the Paroxetine API to be adulterated,” said the advisory.

Paroxetine is used as treatment for depression, obsessive-compulsive disorder and panic disorder with or without agoraphobia.

The FDA said consumers that bought batches of seroxat that are subject of product recall may report to FDA via; or to GSK Philippines Inc at telephone numbers.: +6328648516 and +6328920762 ext. 8643 or mobile nos.: +639178882315 and +639178594598.

Similarly, the FDA said all consumers are being advised to buy their medicines from legitimate pharmacies and drug outlets and ask for official receipt. (HDT/Sunnex)



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