MHRA Class 2 Recall: Zentiva Pharma UK Limited Fingolimod Zentiva 0.5 mg Capsules GB

• Zentiva Pharma UK Limited has recalled one batch of Fingolimod Zentiva 0.5 mg Capsules due to potential metal particle contamination.
• The affected batch is identified by the batch number BN 4L01372H, and no reports have been received regarding adverse reactions or harm.
• Patients who possess the affected batch are advised to contact their pharmacy in the first instance.
• Distributors must stop supplying the affected batch and quarantine remaining stock for return to their supplier using approved processes.

The particles, if present, are known to be small and pose a low risk to the safety or efficacy of the tablets.

Zentiva Pharma UK Limited has initiated a precautionary recall of one batch of Fingolimod Zentiva 0.5 mg Capsules due to the potential risk of contamination with metal particles. The affected batch is identified by the batch number BN 4L01372H. According to the manufacturer, no reports have been received to date regarding any adverse reactions or harm associated with this batch. However, as a precautionary measure, patients who possess the affected batch are advised to contact their pharmacy in the first instance.

The recall is categorized as a Class 2 Medicines Recall by the MHRA, indicating that it poses a low risk to the safety or efficacy of the product. The manufacturer has instructed distributors to stop supplying the affected batch and quarantine all remaining stock for return to their supplier using approved processes. Patients are advised not to discontinue taking their medication without consulting their healthcare professional first. Any suspected adverse reactions should be reported via the MHRA Yellow Card scheme.

This recall serves as a reminder of the importance of vigilance in ensuring the quality and safety of pharmaceutical products. For lawyers and compliance officers, it highlights the need to advise clients on potential risks associated with taking Fingolimod Zentiva 0.5 mg Capsules from the affected batch. Monitoring for adverse reactions or reports of harm is also crucial. The recall underscores the significance of regulatory measures in place to protect public health.

Lawyers and compliance officers should be aware of this recall to advise clients on the potential risks associated with taking Fingolimod Zentiva 0.5 mg Capsules from the affected batch, and to monitor for any adverse reactions or reports of harm.

Source: Original reporting via MHRA