Class 2 Medicines Recall Emerade 300micrograms solution for injection in pre-filled syringe (Pharma Česka Republika S.R.O)

Class 2 Medicines Recall Emerade 300micrograms solution for injection in pre-filled syringe (Pharma Česka Republika S.R.O)

April 7, 2020

Drug alert number: EL (20)A/20

Date issued: 7th April 2020.

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a class 2 patient, pharmacy and wholesaler level medicines recall, to be actioned within 48 hours. Pharmaswiss Česka republika s.r.o. (an affiliate of Bausch & Lomb UK Limited) is recalling all unexpired batches of Emerade 300 microgram auto-injectors (also referred to as pens) from patients due to an error in one component of the auto-injector believed to cause some pens to fail to activate and deliver adrenaline.

This is a recall for Emerade 300 microgram pens only. This is a different alert to that issued on 04 March 2020 for Emerade 150 microgram auto-injectors. Click here to view that alert.

For Emerade 300 micrograms auto-injectors, the MHRA, in conjunction with the Department of Health & Social Care (DHSC) has established that there are sufficient supplies of alternative auto-injectors to allow a recall to patient level.

Healthcare professionals should inform patients and carers that they should therefore return all in-date Emerade 300 micrograms auto-injectors to their local pharmacy once they have obtained a prescription for, and been supplied with, an alternative brand.

Emergency Use Adrenaline Auto-injectors in the Healthcare setting: Adrenaline pens that are currently held by healthcare professionals, i.e. in emergency anaphylaxis kits, dental kits etc. are subject to the recall.

Actions for community pharmacy teams can be found in the alert, which contains links to training materials for all devices.

Contacts for further Information:

For stock enquiries please contact Bausch & Lomb Customer Services, Tel: 020 8781 2991 Email: Pharma_CS@bausch.com

For medical information enquiries please contact the Pharmacovigilance and Medical Information Officer, Tel: 0208 781 5523, Email: Pharmacovigilance.UK@bausch.com

 



Posted in: ,


More Latest News >