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