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.