Class 3 Medicines Recall: Flamingo Pharma UK Ltd, Flucloxacillin Capsules BP 500mg, EL(26)A/32

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Flamingo Pharma UK Ltd have informed the MHRA that certain packs of Flucloxacillin Capsules BP 500mg contain the incorrect PIL. The affected packs contain the PIL for Amoxicillin 500mg Capsules instead of the PIL for Flucloxacillin BP 500mg Capsules.

DMRC Number: DMRC-39902702

Company name:Flamingo Pharma UK Ltd

Product description: Flucloxacillin Capsules BP 500mg- PL: 43461/0071, SNOMED code: 42544111000001101, GTIN: 5060464503320

Details of the affected batch:

Batch No.Expiry DatePack SizeFirst Distributed
160063631/08/202828 Capsules19/05/2026

Background information: 

Flamingo Pharma UK Ltd have informed the MHRA that certain packs of Flucloxacillin Capsules BP 500mg contain the incorrect PIL. The affected packs contain the PIL for Amoxicillin 500mg Capsules instead of the PIL for Flucloxacillin BP 500mg Capsules. Flamingo Pharma UK Ltd estimate that the number of impacted is low however as a precautionary measure, this batch is being recalled.

Advice to Healthcare Professionals: 

Stop supplying the affected batch. Quarantine all remaining stock and return it to your supplier using your supplier’s approved process.

Advice to Patients: 

Patients should be aware that the Patient Information Leaflet (PIL) in a small number of packs of Flucloxacillin BP 500mg Capsules is incorrect. The affected packs contain the PIL for Amoxicillin 500mg Capsules instead of the PIL for Flucloxacillin 500mg Capsules.

Patients may continue to take the capsules as prescribed by your doctor as the quality of the capsules is not impacted by this defect.

No further action is required by patients. This recall is being undertaken as a precautionary measure and applies at Pharmacy and Wholesaler level.

The correct PIL may be found at: Click Here.

Patients who experience adverse reactions or have any questions about their 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 medical information enquiries and information on this product, please email safety@flamingopharma.co.uk, or telephone +44 (0) 800 0668 348.

For stock control enquiries please email sales@flamingopharma.co.uk, or telephone +44 (0) 7784 240228

To access the full recall/alert: Class 3 Medicines Recall: Flamingo Pharma UK Ltd, Flucloxacillin Capsules BP 500mg, EL(26)A/32