Product defects

Product defects

If you suspect or are aware that there is a defect or a fault in a medicine you purchased, take the package to a pharmacy as soon as possible. The pharmacy will investigate the matter together with the marketing authorisation holder (a pharmaceutical company) and send the package for examination, when necessary. The pharmaceutical company will notify Fimea of product defects.

What kind of defects are there?

Despite all quality assurance measures, medicine packages do not always meet the quality criteria.

A product defect may be:

  • An error in the medicine package labelling

  • Qualitatively different medicine, such as discoloured tablets or a missing label

  • A package that contains something else than the expected medicine

  • A defect or a fault in the dose dispenser, such as a pre-filled syringe, automatic injector or a device which enables inhaling the product into the lungs.

The package leaflet describes how the medicine should look. The package leaflet also tells how to administer the medicine and how to use and maintain the dose dispenser. Sometimes a fault or a problem may be due to erroneous use but it may also be related to manufacture.