Chemidex Pharma Ltd has issued a Class 4 Medicines Defect Information – Caution in Use.
In relation to:
Brief description of the problem
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.
Whist NVS has not received or distributed any of affected products & batches we do offer three of the affected products as Special-order items.
|
NVS Product Code(s) |
Product Description | Affected Batch No’s | Expiry Date | First Distributed |
| 568545 | Prednisolone 20mg Rectal Foam, 14D | XDAM | June-2025 | Aug-2024 |
| XDAN | Mar-2026 | Jan-2025 | ||
| XDANA | Mar-2027 | Not yet Distributed | ||
| 89047 | Hydrocortisone Cream 2.5%@@, 15G | 5155032 | Oct-2026 | Jan-2025 |
| 89059 | Hydrocortisone Oint 2.5% @@, 15G. | 5152598 | Sep-2025 | April-2023 |
| 5153432 | May-2026 | Aug-2023 | ||
| 5154575 | Apr-2027 |
Aug-2024 |
Advice for healthcare professionals
There is no risk to product quality because of this issue, therefore the affected batches are not being recalled. Healthcare professionals are advised to exercise caution when dispensing the products and where possible, provide an updated PIL.
What to do next – Please read the attached notification letter (Please click here) and bring the issue to the attention of all relevant colleagues within your business. The updated PIL is available electronically and can be downloaded from the links within the notification letter:
