Direct Healthcare Professional Communication (DHPC) on recall of the epinephrine auto-injector Emerade® 300/500 microgramm pre-filled pen: Patients should replace product
2023.05.26
Active substance: Epinephrine
The marketing authorisation holder Pharma Swiss Česká republika s.r.o. and the distributor Dr. Gerhard Mann chem.-pharm. Fabrik GmbH inform in consultation with the local competent authority (Landesamt für Gesundheit und Soziales, Berlin), that all batches of Emerade® pre-filled pens are recalled on patient level. This is due to the results of an ISO 11608 design assessment study (Functionality test after 1.0-meter free-fall) leading in some of the tested pens to either failure to activate or premature activation. In these cases, the required dose of epinephrine is not released.
All patients who have been prescribed an Emerade® pre-filled pen in the last 24 months should have their physician prescribe an alternative epinephrine auto-injector and return the Emerade® Pen(s) to a pharmacy. To ensure patient safety, Emerade® pen(s) should not be returned to the pharmacy until an alternative epinephrine auto-injector has been received. However, due to the market situation, an alternative epinephrine auto-injector may not be immediately available.
The recalls are monitored by the local competent authorities. Further information on the recall can be found on the homepage of the local competent authority (Landesamt für Gesundheit und Soziales) in Berlin.
Download DHPC / Information letter , Download_VeroeffentlichtAm_EN