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Emerade 150 micrograms solution for injection in pre-filled syringe

Brief description of the problem

Pharmaswiss Česka republika s.r.o. (an affiliate of Bausch & Lomb UK Limited) is recalling all unexpired batches of Emerade 150 microgram auto-injectors (also referred to as pens) 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% 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.

Previous estimations of activation failure were obtained from tests on pens that had been stored in the manufacturing facility. Whereas, the recent results were obtained on pens carried by patients, suggesting an environmental contribution to the risk. Investigations are ongoing to understand this.

For Emerade 150 micrograms auto-injectors, the MHRA, in conjunction with the Department of Health & Social Care (DHSC) has established that there are sufficient supplies of alternative auto-injectors to allow for a recall to patient level. Emerade 150 micrograms auto-injectors is a product intended for use in children who weigh between 15 kg and 30 kg (typically aged 3 to 10 years).

For more information on actions for healthcare professionals, patients, use in schools and the management of anaphylaxis click here.

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