Medicine recalls
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| The United Kingdom: Class 2 Medicines Recall: Emerade 150 micrograms solution for injection in pre-filled syringe |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that Pharmaswiss Česka republika s.r.o. (an affiliate of Bausch & Lomb UK Limited) is recalling all unexpired batches of Emerade 150 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.
Results from manufacturer testing of Emerade auto-injectors recalled from patients in Europe indicate that approximately 13% of pens need higher than normal force to activate, implying a higher risk of activation failure than was previously understood. This applies to all strengths of Emerade.
For Emerade 150 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 for a recall to patient level.
Emerade 300 microgram and Emerade 500 microgram auto-injectors are not being recalled at present as there are insufficient supplies of alternatives to provide replacements. For all patients currently in possession of higher strengths of Emerade auto-injectors (i.e. 300 or 500 microgram auto-injectors), the advice from MHRA and DHSC remains that the risk to the patient of being left without a pen, and therefore having no adrenaline to administer, is greater than allowing them to keep pens that may not activate, especially if two pens are carried. Although the risk of activation failure is now estimated to be higher than was previously reported, most Emerade pens will still activate as intended. Therefore, patients should be advised to retain their unexpired Emerade pens, to avoid being left without access to any adrenaline pens.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/class-2-medicines-recall-emerade-150-micrograms-solution-for-injection-in-pre-filled-syringe-pl-33616-0013-el-20-a-14
In Hong Kong, the above product is not a registered pharmaceutical product. Related news was previously issued by MHRA, and was posted on the Drug Office website on 4 Oct 2019 and 29 Nov 2019.
Ends/Thursday, Mar 5, 2020
Issued at HKT 16:00
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