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Publication #7949
Reference
Drug alert 32/2023
Name
Drug alert class 2 – 32 2023 – Class 2 medicines recall – action within 48 hours – Veriton Pharma Ltd – Epistatus 2.5mg Oromucosal solution pre-filled syringes (PFS)
Categories
Scottish Government
Drug Alerts
Organization
Scottish Government Health and Social Care Directorates
Keywords
NHS
SCOTLAND
DRUGS
SAFETY
RISKS
PHARMACEUTICAL INDUSTRY
MEDICINES RECALL
Description
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).’
Contact Name
Irene Fazakerley
Contact Email
Contact Address
Contact Phone
Created
2023-08-30 00:00:00
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