Class 1 Medicines Recall issued for all Emerade 500 and 300 micrograms auto-injectors

The Medicines and Healthcare products Regulatory Agency (MHRA) issued a National Patient Safety Alert, NatPSA/2023/004/MHRA, on 9 May 2023 covering all unexpired batches of Emerade 500 micrograms (PL 33616/0015) and Emerade 300 micrograms (PL 33616/0014) adrenaline auto-injectors, whose active ingredient is adrenaline (as tartrate)¹. Pharmaswiss Česka republika s.r.o. and distributor Bausch & Lomb UK Limited are recalling the pens from patients, and the alert states that future production of both strengths is on hold, so no further supplies will be available¹.

The recall followed an ISO 11608 Design Assessment study in which some auto-injectors failed to deliver the product or activated prematurely. The alert says the 1-metre free-fall (vertical orientation) pre-conditioning resulted in damage to internal components of the auto-injector, leading either to failure to deliver the product or premature activation, and that this damage was not visibly apparent following the pre-conditioning but was evident only on subsequent functional testing¹. The MHRA says it is unclear what impact this has on auto-injectors in clinical use, and that the recall is a precautionary measure because the issue cannot be identified before the pens are used¹. Anaphylaxis UK describes the concern as the device possibly not working or activating prematurely if it has been knocked, for example by being dropped, and notes that pens with internal damage are not easily identified².

The MHRA, with the Department of Health & Social Care (DHSC), established that there are sufficient supplies of alternative auto-injectors to allow a recall at patient level¹. Alternative brands, EpiPen and Jext, are available in a maximum strength of 300 micrograms¹. The alert states there is evidence to suggest that a single EpiPen (300 micrograms) or Jext (300 micrograms) pen will be a suitable replacement for a single Emerade 500 micrograms pen, based on two studies (including one by the manufacturer of Emerade) comparing blood levels of adrenaline after injection¹. Anaphylaxis UK reports that the studies found a 300 microgram dose given by EpiPen or Jext achieves the same adrenaline level in the blood as Emerade 500².

Actions required of GPs and pharmacy teams were to be completed by 12 May 2023, including stopping supply, quarantining stock and identifying and reviewing affected patients¹. The alert sets out the position for patients and carers:

Why it matters for households

The recall covers every unexpired Emerade 300 and 500 microgram pen held by patients, carers, schools and healthcare settings, including pens in emergency anaphylaxis kits such as dental surgery kits¹. The MHRA advises patients and carers to request a new prescription for an alternative brand, to return Emerade pens to a pharmacy once two equivalent strength replacement pens have been obtained, and to receive training on the new device, because each brand works differently¹. Anaphylaxis UK advises patients to contact their GP by telephone for a replacement prescription and to be trained in the new device when collecting it². The MHRA states that patients should continue to carry two devices at all times in case a second dose of adrenaline is needed before the emergency services arrive¹. Prescribers should issue no more than two auto-injectors per patient of any brand or strength, except where schools require separate pens to be kept on the premises, in which case no more than four pens per child may be considered¹. The alert also sets out what to do in an reaction: administer an adrenaline auto-injector without delay even if there is doubt whether it is anaphylaxis, call 999 immediately afterwards and say it is an emergency case of anaphylaxis, and administer a second auto-injector 5 minutes after the initial dose if there is no improvement or the patient deteriorates after an initial improvement¹. Patients should be advised to use a second auto-injector immediately if the first pen fails to activate despite pressing firmly against the thigh¹. For healthcare professionals restocking anaphylaxis kits, DHSC advice is to stock ampoules with dosing charts, needles and syringes rather than pens of any brand, to preserve pen supplies for patients¹. Further detail on carrying, using and storing these devices is in our guide to adrenaline auto-injectors, and related alerts are collected in the health emergencies and first aid hubs.

What happens next

The actions for GPs and pharmacy teams had a completion date of 12 May 2023¹. The alert gives no date for a resupply of Emerade pens; it states only that future production is on hold and that patients will need to be switched to an appropriate alternative¹.