Dropodex 0.1% w/v Eye Drops, solution
What this means
The MHRA has issued a medicines recall or defect notification. Class 1: risk to life, immediate recall. Class 2: may cause mistreatment or harm, recall within 48 hours. Class 3: unlikely to cause harm, recall within 5 days. Class 4 (defect notification): no recall, caution in use. The medicine remains licensed; only the listed batches are affected. Do not stop treatment without speaking to your doctor or pharmacist.
Class 4 defect notification · DMRC-38371734
| Product | Licence | Active ingredient | GTIN |
|---|---|---|---|
| Dropodex 0.1% w/v Eye Drops, solution | PL: 47069/0003 | Dexamethasone sodium phosphate | 5060132680100 |
Background: Rayner Pharmaceuticals limited have informed MHRA that the Patient Information Leaflet (PIL) and Summary of Product Characteristics (SmPC) for the batches listed in this notification 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. The batches listed as ‘not yet distributed’ have also been manufactured and packed without the phosphate concentration included in the PIL. The MHRA, in discussion with the Department of Health and Social Care, considers these products critical for patients, therefore these batches will not be repackaged and continue to be distributed. They are therefore included in this notification. Information available in the SmPC covers the risk occurrence due to phosphates. However, infor