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Publication #8082
Reference
Drug alert 08/2024
Name
Drug alert class 2 – 08 2024 – Class 2 medicines recall – action within 48 hours – Medac Edac GMBH (T/A Medac Pharma LLP), Sodiofolin 50mg/ml solution for injection/infusion (Folinic acid 400mg/8ml vial)
Categories
Scottish Government
Drug Alerts
Organization
Scottish Government Health and Social Care Directorates
Keywords
NHS
Scotland
Drugs
Safety
Risks
Pharmaceutical Industry
Medicines Recall
Description
medac GmbH (t/a medac Pharma LLP) is recalling the product for the batch specified in this notification due to particles detected during long-term stability tests. As stated in the Summary of Product Characteristics (SmPC): ‘Only clear solutions without visible particles should be used’. This batch is being recalled as a precautionary measure and the root cause investigation remains ongoing.
Contact Name
Irene Fazakerley
Contact Email
Contact Address
Contact Phone
Created
2024-03-12 08:47:00
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