Class 2 recall-Epistatus 2.5mg Oromucosal Solution (pre-filled oral syringes)

Veriton Pharma Limited is recalling a specific batch of Epistatus (midazolam) 2.5mg Oromucosal Solution (pre-filled oral syringes) due to confirmed out of specification results related to the product appearance. Following a market complaint, the batch listed in this notification 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 (SmPC) 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).’

MHRA drug alert date: 30 August 2023

MHRA drug alert link:https://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?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=38dfbc19-9ce6-4702-b9fd-a2966b288eff&utm_content=immediately

Further Information

For medical information enquiries please contact Veriton Pharma Limited by emailing to centralmedicalinformation@veritonpharma.com or via the direct line: +44 (0)1932 690325. For stock control enquiries please contact Veriton Pharma Limited by emailing to orders@veritonpharma.com

Please return all affected stock to your original supplier for credit. Unfortunately we can only accept stock purchased from us (Alliance Healthcare Distribution Limited). Any other stock will be returned to your stores/Pharmacies.