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null Emerade adrenaline pens recalled from consumers

Emerade adrenaline pens recalled from consumers

24.2.2020

The marketing authorisation holder of Emerade adrenaline pens, Pharma Swiss Česká republika s.r.o, has issued a patient-level recall of the products as a precautionary measure. Individual cases have been detected where an Emerade pen has failed to activate on the first attempt. Completing the injection may have required pressing the pen with increased force or making multiple attempts.

Medication users who are in possession of an Emerade pen of any batch shall return the product to a pharmacy. The pen is not an interchangeable product. To receive a substituting product, patients must have a prescription for the substitute product. Patients shall acquire a new adrenaline pen simultaneously or before returning the Emerade pen to a pharmacy.

The marketing authorisation holder has provided pharmacies with instructions on the practical procedures related to the returning of the products.

Emerade pens are used as a first-aid measure in difficult, sudden and life-threatening allergic reactions that require treatment (anaphylaxis), caused by, for example, an insect sting or bite, food, medication or physical exercise.

If you have an Emerade adrenaline pen:

  • Contact your attending physician to get a prescription for a substitute product.
  • Return the Emerade pen to a pharmacy.
  • Before returning the pen, make sure you have acquired a substitute product.

Contact the Emergency Response Centre in all cases involving anaphylaxis

Fimea issues a reminder that all adrenaline autoinjectors are meant to be used as a first-aid measure. Patients shall always seek medical treatment after using an adrenaline pen. Always contact the general emergency number 112, call an ambulance and mention anaphylaxis, even if the patient’s symptoms would seem to be already disappearing. It is advisable to bring the used autoinjector with you.

For further information, please contact

Medeca Pharma AB, representative of the marketing authorisation holder:

Tea Lummi, Area Manager, tel. +358 (0)40 866 9200

Fimea

Tuomo Lapveteläinen, Senior Medical Officer, tel. +358 (0)29 5223375

Timo Mauriala, Head of Unit, tel. +358 (0)29 5223214

E-mail addresses take the form firstname.lastname@fimea.fi.