Asset Publisher
Emerade adrenaline pens recalled from consumers
The marketing authorisation holder of Emerade adrenaline pens, Pharma Swiss Česká republika s.r.o, has issued a recall of the products as a precautionary measure. Tests conducted on Emerade adrenaline pens (auto-injector) have revealed cases where the pen has not worked properly. The dose fails to inject, or it is injected prematurely.
Medication user who are in possession of an Emerade adrenaline pen (any strength or lot) must 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 from the attending physician. Patients must acquire a new adrenaline pen before returning the Emerade pen to a pharmacy.
If you have an Emerade adrenaline pen:
- Contact your attending physician to get a prescription for a substitute product.
- Before returning the pen, make sure you have acquired a substitute product.
- Return the Emerade pen to a pharmacy.
The marketing authorisation holder provides 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 (anaphylactic reaction), caused by, for example, an insect sting or bite, food, medication or physical exercise.
Contact the Emergency Response Centre in all cases involving anaphylaxis
Fimea issues a reminder that all adrenaline pens are meant to be used as a first-aid measure. Patients must 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 adrenaline pen with you.
Ask more
- Sami Paaskoski, Senior Pharmaceutical Inspector, tel. +358 (0)29 522 3237 (matters concerning product defects)
- Piia Vuorela, Director, Tel. +358 (0)29 522 3510 (clinical matters)
- Minna Myllyntausta, Senior Officer, tel. +358 (0)29 522 3230 (matters concerning the availability of medicines)
- The e-mail address format is firstname.lastname@fimea.fi.