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| The United Kingdom: Class 2 Medicines Recall: Veriton Pharma Limited, Epistatus 2.5mg Oromucosal Solution, pre-filled syringe (English only) |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that Veriton Pharma Limited is recalling a specific batch of Epistatus (midazolam) 2.5mg Oromucosal Solution (pre-filled oral syringe) (batch number: 230327A2) due to confirmed out of specification results related to the product appearance.
Following a market complaint, the batch was investigated and it was confirmed that there is potential for some products to appear cloudy and/or contain crystalline particles. The Summary of Product Characteristics states that the product should be a ‘clear colourless to pale yellow solution.’ Additionally, there is specific information that states ‘do not use if the solution is not clear (e.g. cloudy or white particles are present).’
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/class-2-medicines-recall-veriton-pharma-limited-epistatus-2-dot-5-mg-oromucosal-solution-pre-filled-syringe-pfs-el-23-a-slash-32
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Thursday, Aug 31, 2023
Issued at HKT 16:00
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