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Director Letters (formerly MELs/CELs/HDLs etc) are currently being reviewed to ensure it is clear which publications are current, superseded or obsolete.
Publication #7932
Reference
Drug alert 28/2023
Name
Drug alert class 2 – 28 2023 – Class 2 medicines recall – action within 48 hours - medac GmBH (t/a medac Pharma LLP) Sodiofolin 50mg/ml solution for injection/infusion, (100mg/2ml 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
Further to EL(23)/A26 medac GmbH (t/a medac Pharma LLP) have identified further batches that are impacted. medac GmbH (t/a medac Pharma LLP) is recalling the products and respective batches 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.’. These batches are being recalled as a precautionary measure and the root cause analysis investigation remains ongoing.
Contact Name
Irene Fazakerley
Contact Email
Contact Address
Contact Phone
Created
2023-08-21 00:00:00
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