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Flucloxacillin Capsules 500 mg

Active Ingredient:
flucloxacillin sodium
Company:  
Flamingo Pharma (UK) Ltd See contact details
ATC code: 
J01CF05
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About Medicine
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Prescription only medicine
Healthcare Professionals (SmPC) Patient Leaflet (PIL) Safety Alert
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{healthcare_pro_orange} For Healthcare Professionals

CLASS 3 MEDICINES RECALL, EL(26)A/32

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.

Further information can be found in the MHRA Drug Safety Update

Affected Lot Batch Number:

Batch No.: 1600636

Expiry Date: 31/08/2028

Pack Size: 28 Capsules

First Distributed: 19/05/2026

Advice for Healthcare Professionals:

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

Advice for Healthcare Professionals to Provide 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.

Flamingo Pharma (UK) Ltd
Company image
Address
The BLOC, 38 Springfield Way, Kingston Upon Hull, HU10 6RJ, UK
Telephone
+44 (0) 7784240228
Medical Information Direct Line
+44 8000668348
WWW
http://www.flamingopharma.co.uk
Stock Availability
[email protected]