Product defects and recalls

Medicines are manufactured and distributed according to strict regulations to ensure their quality and efficacy. Although it happens rarely, defects may occur in the manufacturing or distribution of medicines which could affect their quality. Should any such events occur, the Danish Medicines Agency has an established process to identify the affected medicines and ensure the medicines are recalled from the market.

The Danish Medicines Agency collaborates with pharmaceutical companies and medicines agencies in other countries if a product defect involving a medicine is suspected. We also assess whether medicines need to be recalled from the market, e.g., from distributors, pharmacies, or in rare cases, the public.

Medicinal product defects include issues such as defects in the packaging material and defects impacting the medicine’s shelf life, but also include cases where the manufacturer does not meet the quality requirements set for the manufacture of medicines.

Suspicion of product defects

If you use a medicine and suspect a product defect you may 

• raise your concern at the pharmacy where you bought the medicine. The pharmacy may then contact the marketing authorisation holder or their representative. It is a good idea to bring with you the product in its original packaging.
• contact the marketing authorisation holder or their representative. You will find contact details in the package leaflet supplied with the medicine.

Reporting and assessment of product defects

Pharmaceutical companies are required to contact the Danish Medicines Agency if they observe defects that could impact the medicine’s quality, safety or efficacy. We may also receive information about product defects from, for instance, pharmacies and healthcare professionals.

Based on factors such as the risk to the patient, we assess whether there is a need to recall the medicinal product. Furthermore, we follow up with the pharmaceutical companies that are to investigate the cause of the defect and prevent it from happening again.

Recall of medicinal products

Before deciding whether recall of a defective medicinal product is necessary, we consider, among other things:

• Does the defect have consequences for patients?
• Will recalling the medicine cause a potential shortage of the medicine?

Recalls can be executed at different levels in the supply chain, for example, distributors or pharmacies. In a product recall, it is often specific batches of the medicine that are recalled.

In rare cases, serious defects are detected that may pose a risk to those using the medicine. In such instances the recall may be effected at the patient level. We will inform patients about the necessary steps they should take if they possess a medicinal product that has been recalled. This information may be disseminated via the media, the website of the Danish Medicines Agency, or digital post directly to the patient.