Medicine recalls
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| The United Kingdom: Class 2 Medicines recall: Emerade 150, 300 and 500 microgram 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 the below products due to an error in one component of the autoinjector believed to cause some pens to fail to activate and deliver adrenaline. There is an increased likelihood of the activation fault occurring when pens are exposed to high temperature. Patients should be advised not to expose pens to temperatures above 25°C as this may increase the likelihood of the fault occurring. The affected products are:
- Emerade 150 micrograms solution for injection in pre-filled syringe
- Emerade 300 micrograms solution for injection in pre-filled syringe
- Emerade 500 micrograms solution for injection in pre-filled syringe
On the basis of all the information available, most Emerade pens will activate as normal and patients are advised to continue to follow existing advice to carry two in-date pens with them at all times. Prescribers should prescribe adrenaline pens (autoinjectors) of another brand, until this error has been corrected and ensure that training is provided for the alternative brands. In the UK, there are insufficient supplies of alternative brands to replace all the Emerade pens held by patients. No further supplies of Emerade will be available until the issue has been fully resolved.
Emerade stock held by patients is not being recalled, and patients and caregivers in possession of Emerade pens need to be informed of updated safety information about the risk of failure to activate.
Please refer to the following website in MHRA for details: http://www.gov.uk/drug-device-alerts/class-2-medicines-recall-emerade-150-300-and-500-microgram-solution-for-injection-in-pre-filled-syringe-mdr-57-08-19
In Hong Kong, the above products are not registered pharmaceutical products. Related news was previously issued by MHRA, and was posted on the Drug Office website on 4 Oct 2019.
Ends/ Friday, Nov 29, 2019
Issued at HKT 15:00 |
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