Class 2 Medicines Recall: Fucidin 250 mg Tablets, LEO Laboratories Ltd trading as LEO Pharma, EL(25)A/38
LEO Pharma is recalling the affected batch as a precautionary measure due to out of specification results for impurities during routine stability testing.
DMRC Number: DMRC-36306427
Company name: LEO Laboratories Ltd trading as LEO Pharma
Product description:
Fucidin 250 mg Tablets
PL: 00043/5000R
Active Ingredient: Sodium Fusidate
SNOMED code: 3670711000001108
Details of the affected batch:
| Batch No. | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| D00993 | 31/01/2026 | 10 x 10 | 13/07/2023 |
Brief description of problem:
LEO Pharma is recalling the affected batch as a precautionary measure due to out of specification results for impurities during routine stability testing.
Advice to Healthcare Professionals:
Stop supplying the above batch immediately. Quarantine all stock and return it to your supplier using your supplier’s approved process.
LEO Pharma can confirm 1,848 packs of this batch have been released and distributed. No related adverse event reports or product quality complaints have been received related to this defect.
Advice to Patients:
No further action is required by patients as this is a Pharmacy and Wholesaler level recall related to a specific batch of Fucidin 250 mg Tablets.
Patients who experience adverse reactions or have any questions about the medication should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme.
Company contacts for further information:
For all enquiries and information on this product, please email medical-info.uk@leo-pharma.com or telephone 01844 347 333 and press 2 for Medical Information.
To access the full recall: