Emerade 300mcg pens recalled over ‘risk of activation failure’
The Medicines and Healthcare products Regulatory Agency (MHRA) has recalled Emerade 300mcg pens due to “a higher risk of activation failure than was previously understood".
Patients who are not self-isolating due to COVID-19 should return their unexpired Emerade 300 micrograms auto-injectors to their pharmacy, once they have a replacement, the MHRA has said.
The MHRA issued the recall on Tuesday (April 7) after the manufacturer, Pharmaswiss Česka republika – an affiliate of Bausch & Lomb UK – said some pens might not activate due to an error in one of its components.
The issue applies to all strengths of Emerade, the manufacturer said. The Emerade 150mcg strength was recalled last month (March 4) and patients are now being encouraged to return their Emerade 300mcg pens, as the MHRA and the Department of Health and Social Care have determined that there are enough alternative pens available.
Healthcare professionals should tell patients to return their Emerade 300mcg pens only “when they have obtained two adrenaline auto-injectors in a different brand”, the MHRA explained.
The regulatory body said it is not recalling the Emerade 500mcg auto-injectors, as there are “insufficient supplies of alternatives to provide replacements”.
The MHRA added that while patients need to return the Emerade 300mcg pens to their pharmacy, once they are provided with a replacement, “this should not require someone who is self-isolating to leave their home”.
Pharmacies could also consider the use of delivery services to ensure that “vulnerable patients and those practising self-isolation, social distancing and shielding can still obtain their replacement auto-injectors”, it said.