The Health Products Regulatory Authority (HPRA) wishes to inform users and healthcare professionals of the following potential quality defect for the Emerade range of treatments
- There is a possibility that a small percentage (0.015%) of Emerade pens on the Irish market may not deliver a dose of adrenaline.
- This is due to the potential for a blocked syringe needle to be in place.
- A blocked needle has been identified by the manufacturer in one Emerade syringe during standard product stability testing.
- While no confirmed reports of a blocked needle have been received from the marketplace for Emerade to date, there is the potential for units on the market to have a blocked needle, and this could lead to an Emerade auto-injector not firing.
- The risk presented by this defect can be reduced by the patient always carrying two pens as described in the approved patient information for Emerade.
Please see the HPRA website for further details.