On November 25, 2025, the Medicines and Healthcare products Regulatory Agency (MHRA) issued a Class 4 Medicines Defect Notification regarding Moclobemide 150mg tablets distributed by Lexon UK Ltd. This notification stems from the omission of critical updated safety information from the Patient Information Leaflet (PIL) within affected batches of the product. Healthcare professionals, particularly those working in clinical, quality, and regulatory roles, should take note of these developments and act accordingly.
What changed?
Lexon UK Ltd informed the MHRA of this packaging defect, which involves missing updated safety details from the Patient Information Leaflet (PIL) enclosed in specific cartons of Moclobemide 150mg tablets. Patient information leaflets serve an essential role in ensuring safety and compliance by providing dosing instructions, warnings, possible side effects, and other critical details. According to the notification, the absent safety information from these leaflets poses a significant risk for patients managing their conditions.
Who is affected?
Healthcare professionals and teams in clinical, quality control, and regulatory capacities are the primary stakeholders impacted by this issue. Patients taking Moclobemide, a pharmaceutical agent mainly prescribed for depression and social anxiety disorders, may face additional risks due to the absence of complete safety guidance. Pharmacists dispensing these affected formulations are urged to ensure that patients receive the correct safety information at the point of dispensing.
Identified batches
The batches involved include cartons distributed under specific production codes. Although the notification did not explicitly list the batch numbers, healthcare teams are advised to reference the official MHRA statement for full details on impacted products. Remaining vigilant in reviewing packaging materials during handling and distribution will help mitigate risks associated with this issue.
Corrective actions required
Clinical and regulatory teams should review their inventories and identify any cartons of Moclobemide 150mg tablets that match the affected batches. Pharmacists are requested to counsel patients actively and provide supplementary safety information when dispensing medications from the impacted stock.
In cases where the leaflets require replacement, stakeholders are encouraged to take the following actions:
- Reach out to Lexon UK Ltd for replacement materials or additional safety information.
- Ensure that all patients currently using Moclobemide 150mg tablets are informed of the missing information and provided with appropriate updates as outlined in the MHRA notification.
Pharmacists should document any actions taken to address or rectify the issue in order to maintain compliance and facilitate traceability.
FAQ
1. What is a Class 4 Medicines Defect Notification?
A Class 4 Medicines Defect Notification is an alert issued by the MHRA when a defect is identified that does not pose an immediate risk to patient health but still requires corrective actions. This classification often involves packaging or labeling issues.
2. How should pharmacies respond to this notification?
Pharmacies should immediately review their stock to identify affected batches and ensure patients are provided with the correct safety information. Staff should also contact the manufacturer for a replacement PIL if required.
3. Where can I find more details about affected batches and actions to take?
The MHRA has detailed the affected batches and outlined necessary steps in its official notification, accessible through the link provided at the end of this article.
Conclusion
Lexon UK Ltd’s notification regarding missing safety details in the Patient Information Leaflet for Moclobemide 150mg tablets highlights the need for vigilance by clinical and regulatory professionals. Immediate steps, such as reviewing stock and directly informing patients, are essential to mitigate risks. Further guidance is available directly from the MHRA.
Disclaimer
This article is intended for informational purposes only and should not be considered legal or regulatory advice. For case-specific guidance, contact a qualified professional.
Official announcement link
For full information about the announcement, see the link below.