Class 2 MHRA medicines recall – Emerade 500 micrograms solution for injection in pre-filled syringe (Pharmaswiss Česka republika s.r.o. (an affiliate of Bausch & Lomb UK Limited)) – PL 33616/0015

Drug alert number: EL(20)A/23

Date issued: 18 May 2020

The Medicines and Health products Regulatory Agency (MHRA) has issued a class 2 medicines recall for:

Emerade 500 micrograms solution for injection in pre-filled syringe (Pharmaswiss Česka republika s.r.o. (an affiliate of Bausch & Lomb UK Limited)) – PL 33616/0015

Pharmaswiss Česka republika s.r.o. (an affiliate of Bausch & Lomb UK Limited) is recalling all unexpired batches of Emerade 500 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.

Actions for healthcare professionals

All healthcare professionals in primary, secondary or specialist healthcare services who prescribe, supply or administer adrenaline auto-injectors, or who advise patients and their carers, should ensure that they:

• identify patients who have been supplied with Emerade 500 micrograms auto-injectors and ensure they are reviewed to determine whether their adrenaline auto-injector prescription is still appropriate and in line with existing guidance;
• immediately inform patients and carers to request a new prescription to replace each Emerade 500 microgram auto-injector with one new 300 microgram adrenaline pen in an alternative brand. Healthcare professionals should be aware that the licensed dosing recommendations for each brand of pen are not identical. They are available in the Summary of Product Characteristics (SmPC) and should be followed (see links in the full alert);
• inform patients to return Emerade 500 microgram auto-injectors to the pharmacy, when they have obtained a total of two adrenaline 300 microgram auto-injectors in a different brand;
  • Although pens should be returned to a pharmacy once a replacement is obtained, this should not require someone who is self-isolating to leave their home (see COVID-19 advice in the full alert)
  • Pharmacies that receive Emerade 500 microgram auto-injectors from patients should quarantine the pens and return them to the supplier using the supplier’s approved process.
• Inform patients:
  • that they should always carry two in-date auto-injectors with them at all times in case they need to administer a second dose of adrenaline before the arrival of the emergency services;
  • that they need to receive training, so they are confident in being able to use any new devices (see further information in document attached to the full alert);
  • of the signs of anaphylaxis and the actions they should immediately take (see Management of Anaphylaxis in the full alert for further advice).
• are aware that this recall also applies to Emerade 500 microgram auto-injectors that are in emergency anaphylaxis kits held by healthcare professionals, such as dental surgery kits etc.
• adrenaline ampoules, as opposed to auto-injectors, should be stocked when renewing the adrenaline in anaphylaxis kits (ensuring dosing charts, needles and syringes are included). See further information in document attached to the full alert
• are aware that this recall also applies to Emerade 500 microgram auto-injectors that are currently held by schools. See further information on the use of pens in school, in document attached to the full alert

The full drug alert including attached documents can be viewed here.

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