A recall has been issued for a batch of Depo-Medrone 80 mg in 2 mL vials due to a critical labeling error. Specifically, the vial’s overlabel inaccurately indicates the contents as 40 mg in 1 mL instead of the correct 80 mg in 2 mL. This discrepancy could lead to dosing errors and potential patient harm. The recall, announced on October 2, 2025, targets healthcare professionals, particularly those in clinical, quality, and regulatory teams, to take immediate action.
What changed?
The Medicines and Healthcare products Regulatory Agency (MHRA) has flagged a labeling issue with a specific batch of Depo-Medrone, an injectable medication commonly used for inflammatory and autoimmune conditions. The vial overlabel erroneously lists the vial content as 40 mg in 1 mL when it should reflect 80 mg in 2 mL. This could result in significant dosage miscalculations if not addressed promptly.
The identified batch has been distributed across various healthcare facilities, making it essential for clinical teams to inspect their inventory immediately.
Who is affected?
This recall directly impacts hospitals, pharmacies, and other healthcare providers using Depo-Medrone. It is critical for medical professionals involved in prescribing, dispensing, or administering injectable medications to be aware of this issue to avoid inadvertent underdosing or overdosing. Regulatory and quality control teams are advised to coordinate auditing measures to identify and segregate affected vials.
What regulatory actions are expected?
The MHRA has classified this recall as a Class 2 action. This category indicates that the defect may cause harm but is not imminent or life-threatening under normal use. The affected batch must be removed from circulation, and healthcare facilities must communicate promptly with suppliers to arrange replacements. Documentation of compliance will likely become part of ongoing evaluations to prevent recurrence.
- Immediate actions: Isolate affected vials based on lot numbers.
- Communication: Notify all relevant staff and departments of the recall.
- Reporting: Inform regulators if affected vials have already been administered.
Maxearn Limited, the distributor, is working closely with regulators to ensure that all affected vials are promptly recovered. Additional guidance will be provided as it becomes available.
FAQ
1. What should healthcare providers do immediately?
Isolate any stock of Depo-Medrone with the identified labeling discrepancy and notify your supplier for further instructions. Avoid using the product until the issue has been resolved.
2. Which batch is affected?
The recall specifically targets a batch labeled erroneously as 40 mg in 1 mL. Check the lot number and consult the MHRA recall notice for detailed identification.
3. What should be done if the medication was already administered?
If the mislabeled medication has been administered, assess dosing accuracy and patient outcomes. Report any incidents or adverse effects to the MHRA Yellow Card Scheme immediately.
Conclusion
This recall highlights the importance of accuracy in medical labeling and the critical role healthcare professionals play in ensuring patient safety. Clinical, quality, and regulatory teams must act promptly to remove mislabeled vials from use and report any associated adverse events. Updates and further instructions from the MHRA and Maxearn Limited should be closely monitored.
Disclaimer
This content is for informational purposes only and does not constitute legal or medical advice. Please consult regulatory guidance or legal counsel for compliance-related decisions.
Announcement
For full information about the announcement, see the link below.