MHRA has issued various safety alerts:
Class 2: Veriton Pharma Limited, Epistatus 2.5 mg oromucosal solution, pre-filled syringe (Veriton Pharma Limited)
One affected batch is being recalled:
|Batch Number||Expiry Date||Pack Size||First Distributed|
|230327A2||09/2024||1 x 0.25ml PFS||05/06/2023|
Active Pharmaceutical Ingredient: Each pre-filled oral syringe contains 0.25ml of
The affected batch has the potential for some products to appear cloudy and/or contain crystalline particles.
In seven affected batches the priming instructions in the current PIL for Tostran 2% gel require updating to ensure an accurate first dose may be delivered. The Patient Information Leaflet and Summary Product Information will be updated.
The following affected batch is licensed only for distribution in Ireland. Although Loceryl is a registered medicine in both Ireland and the UK, there are differences between these products in the product labelling and Patient Information Leaflet (PIL) packaged with the medicine.
|Batch No||Expiry Date||Pack Size||First Distributed|
|2212421*||05 / 2025||1 x 5.0ml||19 August 2022|