Class 4 Medicines Notification, Chemidex Pharma Ltd, Various Products, El(25)a/21

Recall Summary Chemidex Pharma Ltd topical steroid products have incomplete patient information leaflets that are missing details about potential visual disturbance side effects. The affected products and specific batches are listed in the full notification. This recall applies to products distributed in the United Kingdom.

Reason
Chemidex Pharma Ltd has informed the MHRA that the Patient Information Leaflet (PIL) in their topical steroid products does not contain all the required safety information. Cartons for the products/batches listed are missing side effect information related to Visual Disturbances.
Classification
Class III
Category
drug recall
Country
United Kingdom
Agency
UK Medicines and Healthcare products Regulatory Agency
Recall date
2025-05-13
Status
Ongoing
Distribution
United Kingdom

Official recall notice from UK Medicines and Healthcare products Regulatory Agency

Recall details on Nibble Recalls: https://trynibble.app/recalls/4838fca3-ed28-4891-a08e-0549eb6b5572