Safety Alerts & Recalls

What does this mean?

Canesten Pessary 500mg for over the counter (OTC) sale is being recalled only because of an error with the accompanying Patient Information Leaflet (PIL). There are no concerns regarding the actual medication. The PIL in the affected batches still relates to the correct medicine, but it contains fewer safety warnings and precautions than are legally required for a medicine available without prescription.

If you have recently purchased Canesten Pessary 500mg from a pharmacy without a prescription and the batch number on the pack is the same as one of those above, your pharmacist can supply you with the correct PIL. If you have any further questions about this alert or your treatment with Canesten pessary please discuss them with your pharmacist or doctor.

Bayer Recalls Canesten Pessary Due To Patient Information Leaflet Error

Bayer plc, Consumer Care Division, is recalling two batches of Canesten Pessary 500mg packaged for over the counter (OTC) sale. This is because these ‘Pharmacy only’ (P) packs contain the Patient Information Leaflet (PIL) designed for the Prescription Only (POM) version of the product. ‘P’ products are available to buy from pharmacies without prescription so the PIL in these packs includes additional safety warnings and precautions not present in the ‘POM’ leaflet.

The batch numbers affected by this recall are BXFWKG1 and BXFTDV1.

Canesten Pessary contains clotrimazole, an antifungal medicine used to treat vaginal thrush.

Please note that there are other Canesten and clotrimazole preparations available, but this alert only affects the Canesten pessary 500mg.

For further information please visit: more information here

Source: MHRA
Publication Date: 2011-06-22
Last Updated: 2011-06-22

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