Medicine recalls
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| The United Kingdom: Class 2 Medicines Recall: Emerade 500 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 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.
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. Previous estimations of activation failure were obtained from tests on pens that had been stored in the manufacturing facility. Whereas, the recent results were obtained on pens carried by patients, suggesting an environmental contribution to the risk. Investigations are ongoing to understand this.
For Emerade 500 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. The recall of Emerade 500 microgram auto-injectors from patients follows a previous recall of Emerade 150 microgram auto-injectors and Emerade 300 microgram auto-injectors from patients.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/class-2-medicines-recall-emerade-500-micrograms-solution-for-injection-in-pre-filled-syringe-pl-33616-0015-el-20-a-23
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, 29 Nov 2019, 5 Mar 2020 and 8 Apr 2020.
Ends/Tuesday, May 19, 2020
Issued at HKT 15:00
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