Drug alert number: EL (23)A/32
Date issued: 30 August 2023
The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a class 2 medicines recall for: Epistatus 2.5 mg oromucosal solution, pre-filled syringe (PFS) (Veriton Pharma Limited) PLGB 16786/0015
SNOMED Code: 41927911000001101
1 x 0.25ml PFS
Active Pharmaceutical Ingredient: Each pre-filled oral syringe contains 0.25ml of midazolam maleate corresponding to 2.5mg midazolam.
Brief description of the problem
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).’
Advice for healthcare professionals
Stop supplying the above batch immediately. Quarantine all remaining stock and return it to your supplier using your supplier’s approved process.
Healthcare settings should consider using other batches or midazolam from alternative providers to administer emergency doses as required. The opalescent product in the impacted batch has been shown to contain sufficient midazolam and could be used in an emergency where alternate medicine is not available. The recall is being carried out as a precautionary measure to mitigate any further concerns with syringes that are not as described in the SmPC.
Full drug alert can be viewed here.
For medical information enquiries please contact Veriton Pharma Limited by emailing to firstname.lastname@example.org or via the direct line: +44 (0)1932 690325. For stock control enquiries please contact Veriton Pharma Limited by emailing to email@example.com