Medicine recalls
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| The United Kingdom: Class 2 Medicines Recall: Glaxo Wellcome UK Limited (trading as GlaxoSmithKline UK), Flolan 1.5 mg Powder and Solvent for Solution for Infusion |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that Glaxo Wellcome UK Ltd (GSK) has informed the MHRA that vials of Flolan 1.5 mg Powder and Solvent for Solution for Infusion (epoprostenol sodium) (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 the affected 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 the affected batch and the batch is being recalled as a precautionary measure to mitigate the risks.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/class-2-medicines-recall-glaxo-wellcome-uk-limited-trading-as-glaxosmithkline-uk-flolan-1-dot-5-mg-powder-and-solvent-for-solution-for-infusion-el-24-a-slash-30
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Tuesday, Jul 23, 2024
Issued at HKT 16:00
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