Swissmedic has issued an official recall for specific batches of Spersallerg SDU 20 monodose eye drops. This recall applies to batches 9T48 and 2V33 at the patient level, effective October 3, 2025. The announcement underscores regulatory concerns about the quality and safety of these productions. Healthcare professionals, regulatory teams, and clinical staff must take immediate action to manage the recall and minimize patient risk.
Quick Links:
- What changed?
- Who is affected?
- What are the next steps?
- Frequently Asked Questions
- Conclusion
- Disclaimer
- Swissmedic Official Notice
What changed?
On October 3, 2025, Swissmedic notified stakeholders of the recall of Spersallerg SDU 20 Single-Dose Units manufactured under batches 9T48 and 2V33. According to Swissmedic, this recall was necessary to address identified quality issues. The recall demands actions at the patient level to ensure traceability and mitigate risks associated with the affected batches.
Who is affected?
The recall primarily impacts clinical settings, including hospitals, pharmacies, and individual patients. Healthcare professionals in ophthalmology and those dispensing Spersallerg must act promptly to address the issue. Regulatory and quality assurance teams will play a critical role in managing compliance with this recall notice.
Implications for patients
Patients using Spersallerg batches 9T48 and 2V33 should stop use immediately and consult healthcare providers for guidance. Pharmacists and clinical staff must ensure substitute products are available to avoid therapy disruption.
What are the next steps?
Healthcare providers and regulatory teams should take the following steps:
- Identify if affected batches are in stock or distributed.
- Notify patients using these products immediately and instruct them to discontinue use.
- Arrange the safe return or disposal of recalled units following Swissmedic directions.
- Report any adverse events related to these batches to Swissmedic.
Documentation is key during such recalls to demonstrate compliance with Swissmedic guidelines.
Frequently Asked Questions
Q1: Why were these batches recalled?
Swissmedic identified quality concerns with batches 9T48 and 2V33, rendering them unsuitable for patient use.
Q2: How can I confirm if I have an affected batch?
The batch number is marked on the packaging of Spersallerg SDU 20 monodose products. Check your product for batch numbers 9T48 or 2V33.
Q3: What should patients do if they have these batches?
Patients should stop using the product immediately and contact their healthcare provider for further instructions.
Conclusion
Swissmedic’s recall notice highlights the importance of vigilance in product monitoring. Healthcare providers and regulatory personnel must act swiftly to ensure patient safety and compliance. Follow the recommended guidelines to handle the recall effectively.
Disclaimer
This article provides general information for healthcare professionals and regulatory teams. It does not offer legal advice or replace official guidance.
Swissmedic Official Notice
For full information about the Swissmedic announcement, see the link below.