Class 4 MHRA drug alert – Emerade 150, 300 and 500 microgram pre-filled syringe

Class 4 MHRA drug alert – Emerade 150, 300 and 500 microgram pre-filled syringe

October 3, 2019

Class 4 MHRA drug alert

Emerade 150 micrograms solution for injection in pre-filled syringe – PL 33616/0013
Emerade 300 micrograms solution for injection in pre-filled syringe – PL 33616/0014
Emerade 500 micrograms solution for injection in pre-filled syringe – PL 33616/0015

Drug alert number: EL (19)A/23

Date issued: 3rd October 2019

The Medicines and Health products Regulatory Agency (MHRA) has issued a class 4 pharmacy level caution in use for:

Emerade 150 micrograms solution for injection in pre-filled syringe – PL 33616/0013
Emerade 300 micrograms solution for injection in pre-filled syringe – PL 33616/0014
Emerade 500 micrograms solution for injection in pre-filled syringe – PL 33616/0015

The MHRA has notified Bausch and Lomb UK Limited of reports that Emerade pens have failed to activate. This is not related to the risk of needle blockage reported in the previous drug alert. The activation failures have not been traced to particular batches. Bausch and Lomb UK Limited are conducting a thorough investigation to identify the reason. Following discussions with alternative adrenaline auto-injector suppliers there are currently sufficient supplies available to meet historic demand. However, there are insufficient surplus devices to replace all the Emerade pens that would need to be recalled. Therefore, at present, the MHRA is advising that Emerade devices should not be recalled.

Healthcare Professionals are urged to share this information with patients and carers who have been prescribed an Emerade pen, to reinforce the advice to always carry two in-date adrenaline autoinjectors with them at all times. This advice is provided in the approved patient information leaflet for Emerade, which should be provided to the patient or caregiver at dispensing.

For stock enquiries please contact Bausch & Lomb Customer Services:

Tel: 0208 781 2991 Email: Pharma_CS@bausch.com

For medical information enquiries please contact Lizanne Kombrink, Pharmacovigilance and Medical Information Officer:

Tel: 0208 781 5523 Email: Pharmacovigilance.UK@bausch.com

To view the alert please visit the GOV.UK website.



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