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 reference number
DMRC-36306427
Marketing Authorisation Holder
LEO Laboratories Ltd trading as LEO Pharma
Medicine Details
Fucidin 250 mg Tablets
PL: 00043/5000R
Active Ingredient: Sodium Fusidate
SNOMED code: 3670711000001108
GTIN: 05702191000931
Affected Lot Batch Numbers
| Batch No. | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| D00993 | 31/01/2026 | 10 x 10 | 13/07/2023 |
Background
LEO Pharma is recalling the affected batch as a precautionary measure due to out of specification results for impurities during routine stability testing.
Advice for 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 for 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.
Additional 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.
Recipients of this Medicines Recall should bring it to the attention of relevant contacts by copy of this notice. NHS regional teams are asked to forward this to community pharmacists and dispensing general practitioners for information.
Yours faithfully
Defective Medicines Report Centre
10 South Colonnade
Canary Wharf
London
E14 4PU
Telephone +44 (0)20 3080 6574
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