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Publication #7909
Reference
Drug alert 22/2023
Name
Drug alert class 2 – 22 2023 – Class 2 medicines recall – action within 48 hours - Medac GmBH (T/A Medac Pharma LLP) – Dacarbazine 100mg, 200mg & 500mg powder for solution for injection vials
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 products and respective batches in this notification due to pink discolouration of the dacarbazine solution immediately after reconstitution (after correct preparation and storage). As stated in the Summary of Product Characteristics (SmPC), the diluted solution for infusion should be visually inspected and only clear solutions practically free from particles should be used. Do not use the solution if particles are present. The pink discolouration is caused by a degradation product of dacarbazine and may cause a venous irritation in the patient when the product is applied.
Contact Name
Irene Fazakerley
Contact Email
Contact Address
Contact Phone
Created
2023-07-04 00:00:00
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