A mistake in the package insert leads to the withdrawal of a common antibiotic in Britain

 

UK health authorities have ordered the withdrawal of a batch of a common antibiotic from pharmacies and wholesalers, after discovering an error in the leaflet included with some packages

UK health authorities have ordered the withdrawal of a batch of a common antibiotic from pharmacies and wholesalers, after discovering an error in the leaflet included with some packages.

Flamingo Pharma UK Limited issued a notice to the UK Medicines and Healthcare products Regulatory Agency (MHRA), explaining that some packs of Flucloxacillin BP 500 mg capsules contained an information leaflet for Amoxicillin 500 mg, instead of the correct leaflet for Flucloxacillin.

Accordingly, the company asked pharmacies and wholesalers to stop dispensing or distributing the affected batch, and to isolate any remaining stock and return it to the supplier, noting that the decision comes as a precautionary measure even though the number of affected packages is limited.

The health authorities confirmed that the error does not affect the quality or effectiveness of the capsules, and patients who received the medication can continue to take it according to the doctor's instructions. There is no need to take any additional measures, but patients must be informed that the accompanying leaflet is incorrect.

Flucloxacillin is a penicillin-class antibiotic used to treat a range of bacterial infections, including skin and wound infections such as cellulitis and infected eczema, as well as bone and ear infections. It is available by prescription only, and approximately 1.6 million people in the UK use it annually through more than 3 million prescriptions.

The authorities advised patients who experience side effects or have questions about the drug to consult their doctor or pharmacist, and also called for any suspected side effects to be reported via the Medicines and Healthcare products Regulatory Agency's yellow card system.

The affected packages bear the batch number 1600636, with an expiry date of August 31, 2028. Each package contains 28 capsules, and their distribution began on May 19, 2026.


 

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