Publication #8199

Reference
Drug alert 26/2024
Name
Drug Alert Class 2 Drug Alert 26 2024 – Class 2 medicines recall – action within 48 hours – Accord Healthcare Ltd – Kent Pharma UK – Itraconazole 10mg/ml solution
Categories
Scottish Government Drug Alerts
Organization
Scottish Government Health and Social Care Directorates
Keywords
NHS Scotland Drugs Safety Risks Pharmaceutical Industry Medicines Recall
Description
Kent Pharma UK is recalling the above batches of Itraconazole 10mg/ml Oral Solution as a precautionary measure due to out of specification in the appearance of the solution, particularly the presence of suspended particles or clusters of crystals. Initial investigations indicate that this is a solubilisation issue of the active ingredient for the above batches. This means that there is the potential for some doses to have lower active ingredient (itraconazole) in solution. The root cause of this issue is under investigation, but based on the potential for underdosage, the impacted batches are being recalled as a precautionary measure. 

Contact Name
Irene Fazakerley
Contact Address
Contact Phone

Created
2024-07-04 08:27:00


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