Rayner Pharmaceuticals Limited, Dropodex 0.1% w/v eye drops defect

The Medicines and Healthcare products Regulatory Agency (MHRA) has published a Class 4 medicines defect notification for Dropodex 0.1% w/v eye drops. Rayner Pharmaceuticals limited have informed the MHRA that specific batches do not include the concentration of phosphates in the product information.

The Patient Information Leaflet (PIL) and Summary of Product Characteristics (SmPC) for these batches were not updated in accordance with the ‘Annex to European Commission guideline on excipients in the labelling and package leaflet of medicinal products for human use’, which require the concentration of phosphates to be included.

Further information, advice and details of the affected batches can be found on the MHRA website.