IGMPI India

GlaxoSmithKline (GSK) Philippines Inc. has issued a voluntary recall of its anti-depressant medicine, Paroxetine 20 mg tablet (Seroxat). The recalled drugs were manufactured in Romania. GlaxoSmithKline plc (GSK) is a British multinational pharmaceutical, biologics, vaccines and consumer healthcare company headquartered in Brentford, London. GSK manufactures drugs and vaccines for major disease areas such as asthma, cancer, infections, diabetes, digestive and mental health conditions, the biggest selling of which were Advair, Avodart, Flovent, Augmentin, Lovaza, and Lamictal.

The company has recalled Paroxetine 20 mg tablet with batch numbers 601, 602M and 603. According to FDA the non-compliance to current Good Manufacturing Practices (cGMP) had resulted in the voluntary recall of specific batches of Paroxetine 20 mg tablet. FDA also mentioned that SmithKline Beecham (Cork) Ltd. at Currabinny Carriagaline Cork, Ireland had critical deviations which caused the Paroxetine API (active pharmaceutical ingredient) to be adulterated.

Paroxetine is used in treatment for depression, obsessive-compulsive disorder and panic disorder with or without agoraphobia or the fear of public places. The FDA said that 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.