Product defects and withdrawal of medicines 2011
In 2011, 356 reports of medicinal product defects were registered, which is the highest number ever. The majority of the reports came from companies and other authorities and predominantly concerned defects on the package and packaging material and deviations from specifications. In addition, compliance checks of product labelling and package leaflets carried out by the Danish Health Authority generated an increase in the number of reports.
About one third of all reports resulted in actual withdrawals of medicines from the Danish market, which is also an increase than the year before. Almost all withdrawals were effected based on reports from companies and from the Danish Health Authority's own control system. The withdrawals were mainly caused by the defect types 'packaging, bottling/filling and labelling' as well as 'package defects'.
12 reports were caused by counterfeit medicines in the legal supply chain, primarily on non-European markets. In 2011, we did see one counterfeit product on the Danish market, which resulted in a withdrawal.