BANGKOK, 10 May 2013 The Food and Drug Administration (FDA) has indicated that it found no materials that were close to expiring in its inspection of the Government Pharmaceutical Organization-produced Osel Tamivir flu medicines.
FDA secretary-general Bunchai Sombunsuk said FDA inspectors found that the raw materials alleged of being close to expiry were purchased from Indian manufacturers during 2008 and 2009. The materials were used to make the GPO-A-FLU influenza medicine to deal with the flu outbreak during those two years. The first production run by the Government Pharmaceutical Organization (GPO) churned out 1,540 kilograms of the flu medicine, and the 2nd run produced 4,300 kilograms. Scrutiny of the 3,400 kilograms of the remaining raw ingredients found proper labels for the date of production and the date of the latest analysis. However, officials could not find labels for the expiry date. Examination of documents detailing analysis of the materials also failed to yield the expiry date.
According to the GPO, it will carry out another analysis of the raw materials that were major ingredients of the flu medicine. Department officials asserted that materials that fail the analysis criteria will not be used, and that the Department of Medical Sciences will also conduct its own analysis of the materials. ]
