Product defects and withdrawal of medicines 2010
In 2010, the Danish Medicines Agency received a total of 262 reports on product defects involving medicines. This is the highest number of reports received within the past five years.
The increase in the total number of reports is generated by a general increase across all types of product defects. For example, 2010 saw more reports related to non-compliance with GMP, implying that the companies have failed to observe the rules on Good Manufacturing Practice.
The year also saw more reports of defects related to the product itself as well as variation applications ending with withdrawals. The majority of reports came from other authorities and companies. Eight of the 262 reports were caused by counterfeit medicines in the legal distribution chain, which, however, did not affect the Danish market.
About 24 % of the reports resulted in medicines being withdrawn from the Danish market. The majority of the withdrawals were reported by companies and were primarily caused by 'packaging defects' and 'packaging, bottling/filling and labelling'.