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Publication #8447
Reference
Drug Alert 21/2025
Name
Drug Alert class 4 – No 21 2025 – Class 4 medicines defect information – caution in use – Chemidex Pharma Ltd – various topical steroid products
Categories
Scottish Government
Drug Alerts
Organization
Scottish Government Health and Social Care Directorates
Keywords
NHS
Scotland
Health Boards
Special Health Boards
Serious Shortage Protocols
Pharmacy Contractors
Description
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.
The batches listed as ‘not yet distributed’ have also been packed with the PIL that is missing the additional side effect information. 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 the notification and the expected distribution dates for these batches will take place from May 2025.
Contact Name
Irene Fazakerley
Contact Email
Contact Address
Contact Phone
Created
2025-05-13 11:38:10
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