MHRA issues alert for Emerade AAIs
12 July 2019
Products: Emerade 150, 300 and 500 microgram solution for injection in pre-filled syringe - PL 33616/0013, PL 33616/0014, PL 33616/0015
Bausch & Lomb UK limited has informed the Medicines and Healthcare Products Regulatory Agency (MHRA) of a risk of Emerade products failing to deliver a dose of adrenaline from the syringe due to blockage of the needle.
The potential for units on the market to have a blockage of the needle which could lead to Emerade failing to deliver a dose when activated is estimated to be 0.23 %, which would affect 2.3 in every thousand pens. based on simulated laboratory conditions without the auto-injector component.
The notification of potential for needle blockage applies to Emerade devices of all strengths. It does not apply to the other marketed brands of adrenaline auto-injectors.
The MHRA is not recalling batches of Emerade as different brands require specific training and advice and there are insufficient supplies available of alternative brands to support the removal of one brand.
The manufacturer conducted extensive investigations and has implemented corrective actions. Emerade devices manufactured with all the corrective processes are expected to be introduced into the market from mid-July 2019.
The BDA understands from members who have contacted Bausch & Lomb that refunds are not being given, because this is warning is not a recall; it is advice to have more than one AAI available, as the percentages of not being able to deliver a dose of adrenaline before the emergency services arrive is substantially reduced (from 0.23% if there is one to 0.000529% if there are two).
Unfortunately, members may struggle to get a second Emerade AAI due to potential shortages. However as per the Chief Dental Officer's advice on the issue you should be purchasing ampoules when your AAIs run out.
Contact details 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 Lizanne Kombrink, Pharmacovigilance and Medical Information Officer:
Tel: 020 8781 5523 Email: Pharmacovigilance.UK@bausch.com
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