Class 4 Drug Alert: Caution in Use – Emerade® solution for injection pre-filled syringe 150mcg, 300mcg and 500mcg

03 Oct 2019

A Class 4 medicines defect information alert has been issued by the Medicines & Healthcare products Regulatory Agency (MHRA) for Emerade® solution for injection pre-filled syringe in all strengths; 150mcg, 300mcg and 500mcg. This must be actioned within 72 hours with notification to patient level.

Ref: EL (19)A/23

3 October 2019

Emerade® solution for injection pre-filled syringe 150mcg, 300mcg and 500mcg.

Manufactured by Pharmaswiss Česka republika s.r.o. (an affiliate of Bausch & Lomb UK Limited)

Product Product Licence (PL) number
Emerade® solution for injection in pre-filled syringe 150 micrograms PL 33616/0013
Emerade®solution for injection in pre-filled syringe 300 micrograms PL 33616/0014
Emerade® solution for injection in pre-filled syringe 500 micrograms PL 33616/0015

Bausch & Lomb UK limited has identified a risk of certain units of Emerade® device in all strengths that have failed to activate. This is not related to the risk of needle blockage reported in the previous Drug Alert. The MHRA have provided further advice for patients/carers if pen activation failure occurs.

Healthcare professionals, including pharmacists, are advised to contact all patients/carers, who have been supplied with an Emerade® device to share the advice from the MHRA and reinforce the recommendation to carry two in-date adrenaline auto injectors with them at all times. The patient should also be advised that, when used, the pen needs to be pressed very firmly against the thigh, if activation failure occurs, the patient should use the second pen immediately. If the patients condition does not improve and they require a second dose of adrenaline then administration using the pen which failed to activate should be reattempted.

This activation failures have not been linked to specific batches of Emerade.

The MHRA is not recalling Emerade pens.

Further information can be found on the MHRA section on the GOV.UK website.

Produced by the NPA Pharmacy Services team October 2019.