Alert: Dropodex 0.1% w/v eye drops

Rayner Pharmaceuticals has advised that 15 batches of Dropodex 0.1% w/v eye drops solution (dexamethasone sodium phosphate) have missing Patient Information Leaflet (PIL) and Summary of Product Characteristics (SmPC) relating to the concentration of phosphates in the product information.

View the affected batches.

GP teams are advised that this product contains 1.01 mg phosphates in each 0.4 mL dose which is equivalent to 2.52 mg/mL phosphates (from 9.5 mg/mL disodium phosphate dodecahydrate). When topically administered phosphates may lead to corneal deposits or corneal opacity.

The quality of the eye drops is not impacted by the missing information and patients should continue to use the product as instructed.

For all medical information enquiries and information on this product, please email: medinfo.Rayner@apcerls.com, or telephone +44-800-041-8153

For stock control enquiries please email markclayton@rayner.com, or telephone 01903 258777.

MHRA alert