A batch of Fucidin 250mg tablets is being recalled as a precaution after routine stability testing found ‘out-of-specification results for impurities’.
The recall affects Fucidin 250mg tablets (PL 00043/5000R) – batch number: D00993. The batch has an expiry date of 31 January 2026, is in a pack size of 10 x 10, and was first distributed on 13 July 2023.
The product, manufactured by LEO Laboratories Ltd, trading as LEO Pharma, contains the active ingredient sodium fusidate and are used to treat staphylococcal infections.
Healthcare professionals have been advised to stop supplying the affected batch immediately.
Any remaining stock should be quarantined and returned to the supplier via the approved process.
LEO Pharma confirmed that 1,848 packs of the affected batch have been released and distributed. No adverse event reports or quality complaints related to the issue have been received.
Patients have been advised that no further action is required as this is a pharmacy and wholesaler level recall related to a specific batch of Fucidin 250mg tablets.
‘Patients who experience adverse reactions or have any questions about their medication should seek medical attention,’ the MHRA said.
‘Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme.’
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