Lupin Healthcare (UK) Limited has informed us that the affected batches above (also distributed by Discovery Pharmaceuticals /Dexcel Pharma Limited) have been packaged with a version of patient information leaflet that does not include the most up to date safety information.
There are no concerns with the quality, safety and efficacy of the product. However, the affected batches are being recalled due to concerns around the omission of the safety information. Please refer to the alert for the missing information in the PIL.
Advice for healthcare professionals:
Stop supplying the above batches immediately. Quarantine all stock and return it to your supplier using your supplier's approved process.
As a general reminder, pateitns who experience side effects from taking any medicines should be encouraged to report a suspected problem or incident via the Yellow Card Scheme and seek medical advice accordingly.
Full details of the drug alert are included in the attached PDF file. Please forward to listed recipients. This information is also published on the MHRA website
https://www.gov.uk/drug-device-alerts