MANILA, Philippines - The Food and Drug Administration (FDA) yesterday advised the public of the recall of certain batches of a drug used to treat some mental conditions.
FDA director general Kenneth Hartigan-Go said GlaxoSmithKline (GSK) Phil. Inc. initiated the recall of batch nos. 601, 602M and 603 of Paroxetine 20 mg tablet (Seroxat).
“A warning was issued by the US-FDA to GSK USA because the active pharmaceutical ingredients (API) of the manufacturer, SmithKline Beecham (Cork) Ltd. in Currabinny Carriagaline Cork in Ireland, has critical deviations which caused the Paroxetine API to be adulterated,†Go said in an advisory.
This is a violation of the current Good Manufacturing Practice (GMP), which is being enforced by the US FDA.
The US FDA provides the system that ensures proper design, monitoring and control of manufacturing processes and facilities for medicine.
Paroxetine is used to treat depression, obsessive-compulsive disorder and panic disorder with or without agoraphobia.
“Consumers are advised to buy medicine from legitimate pharmacies and drug outlets and ask for official receipt,†Go said.