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

11 Jul 2019

A Class 4 medicines defect information alert has been issued by the Medicines & Healthcare products Regulatory Agency (MHRA) for certain units of 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/17

11 July 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 failing to deliver a dose of adrenaline from the syringe due to blockage of the needle. Healthcare professionals, including pharmacists, are advised to contact all patients/carers, who have been supplied with an Emerade® device to inform them of the potential defect and reinforce the recommendation to carry two in-date adrenaline auto-injectors with them at all times.

The MHRA is not recalling batches of Emerade®.

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

Produced by the NPA Pharmacy Services team July 2019.