MHRA 发布 Flamingo Pharma UK Ltd 氟氯西林胶囊 BP 500mg 三级药品召回（EL(26)A/32）

Contents

1. DMRC reference number
2. Marketing Authorisation Holder
3. Medicine Details
   1. Flucloxacillin Capsules BP 500mg
4. Affected Lot Batch Numbers
5. Background
6. Advice for Healthcare Professionals
7. Advice for Patients
8. Additional information
9. Download document

DMRC reference number

DMRC-39902702

Marketing Authorisation Holder

Flamingo Pharma UK Ltd

Medicine Details

Flucloxacillin Capsules BP 500mg

PL: 43461/0071

Active ingredient: flucloxacillin sodium

SNOMED code: 42544111000001101

GTIN: 5060464503320

Affected Lot Batch Numbers

Background

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 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 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.

Additional information:

For all medical information enquiries and information on this product, please email [email protected], or telephone +44 (0) 800 0668 348.

For stock control enquiries please email [email protected], or telephone +44 (0) 7784 240228

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

[email protected]

Download document

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