In spite of quality control, errors can occur in the manufacture of medicines. These errors are called product defects. The most common defects are errors in the labelling of medicine packages or errors on the packaging process. Fimea always publicises any serious, life-threatening product defects.
A defective manufacturing lot is usually withdrawn from distribution and sales. If a defective manufacturing lot is dangerous to the user's health, it is withdrawn from the consumers as well.
Report a product defect to a pharmacy
In case of a product defect, the holder of a marketing authorisation or registration, i.e. a pharmaceutical company, is responsible for taking appropriate measures and withdrawing the defective medicines from the market or from the consumers. The measures and their urgency depends on the severity of the defect. Fimea monitors that such measures are adequate and carried out at the right time.
In addition, all operators in the pharmaceutical sector – such as pharmaceutical manufacturers, pharmacies and hospital pharmacies – are responsible for taking any required and appropriate actions in case of a product defect. Fimea may prohibit the distribution, sales and consumption of a defective lot of a medicine.
If you suspect a product defect in a medicine, contact a pharmacy.