News » MHRA alert » Alert: oxcarbazepine Mylan film-coated tablets
June 18th 2024
Viatris UK Healthcare Ltd has issued an alert relating to batches of several strengths of oxcarbazepine Mylan film-coated tablets.
The alert relates to incorrect PILs. Affected batches in strengths - 150mg, 300mg and 600mg – are not being recalled.
The affected batches are:
150mg:
|
Batch Number |
Expiry Date |
Pack Size |
First Distributed |
|
A4659 |
03/2026 |
50 |
29/02/2024 |
|
A4660 |
04/2026 |
50 |
Not yet distributed |
300mg:
|
Batch Number |
Expiry Date |
Pack Size |
First Distributed |
|
N3560 |
02/2026 |
50 |
05/02/2024 |
|
A4705 |
02/2026 |
50 |
18/03/2024 |
600mg
|
Batch Number |
Expiry Date |
Pack Size |
First Distributed |
|
M3556 |
12/2025 |
50 |
09/02/2024 |
The affected sections of the PIL are summarised in Appendix 1 of this notification.
Corrected PILs are up to date and can be accessed via the following links:
Oxcarbazepine Mylan 150 mg Film-coated Tablets - Patient Information Leaflet (PIL)
Oxcarbazepine Mylan 300 mg Film-coated Tablets - Patient Information Leaflet (PIL)
Oxcarbazepine Mylan 600 mg Film-coated Tablets - Patient Information Leaflet (PIL)
Hard copies of the updated PIL can also be requested from Viatris UK Healthcare Ltd.
Patients do not need to take any action.
For medical information and stock control queries please contact:
Viatris UK Healthcare Limited Medical Information at +44 (0)1707 853 000 (select option 1) or info.uk@viatris.com. Customer Services can be reached at +44 (0)1707 853 000 (select option 2).
