The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a class 2 medicines recall for Emerade 150 micrograms solutions for injection in pre-filled syringe (auto-injectors).
Pharmaswiss Česka republika s.r.o. , an affiliate of Bausch & Lomb UK Limited, is recalling all unexpired batches of the product from patients due to an error in one component of the auto-injector believed to cause some pens to fail to activate and deliver adrenaline.
“Results from manufacturer testing of Emerade auto-injectors recalled from patients in Europe indicate that approximately 13 per cent of pens need higher than normal force to activate, implying a higher risk of activation failure than was previously understood. This applies to all strengths of Emerade,” the MHRA alert read.
The government agency assured that there are sufficient supplies of alternative auto-injectors to allow for a recall to the patient level.
Healthcare professionals are asked to inform patients and carers that they should return all in-date Emerade 150 micrograms auto-injectors to their local pharmacy once they have obtained a prescription for, and been supplied with, an alternative brand.
Pharmacists and pharmacies who receive the auto-injectors from patients should quarantine and return the product using the supplier’s approved process.