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Publication #8217
Reference
Drug alert 30/2024
Name
Drug Alert Class 2 Drug Alert 30 2024 – Class 2 medicines recall – action within 48 hours – Glaxo Wellcome Ltd (Trading as GlaxoSmithKline UK), Flolan 1.5mg powder and solvent for solution for infusion
Categories
Scottish Government
Drug Alerts
Organization
Scottish Government Health and Social Care Directorates
Keywords
NHS
Scotland
Drugs
Safety
Risks
Pharmaceutical Industry
Medicines Recall
Description
Glaxo Wellcome UK Ltd (GSK) has informed the MHRA that vials of Flolan 1.5 mg Powder and Solvent for Solution for Infusion, batch number AB8M may have been damaged during the packaging process. The potential damage to the vials might not be visible to the naked eye and this could compromise the integrity of the vial and quality of the medicine. As a precautionary measure GSK are recalling this batch. GSK have confirmed that no other batches are impacted, and the other batches remain available to provide immediate re-supply to patients. An investigation is underway to identify the root cause of the problem.
The MHRA and GSK have not been made aware of any adverse events related to this batch and the batch is being recalled as a precautionary measure to mitigate the risks. The information in this recall reinforces action already being undertaken by GSK and ensures that healthcare professionals in NHS Trusts and other care settings take appropriate action to recall the impacted batch from patients as soon as possible.
Contact Name
Irene Fazakerley
Contact Email
Contact Address
Contact Phone
Created
2024-07-22 09:13:00
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