On November 27, 2025, Swissmedic announced an immediate recall of batch number 100062289 of Azelastin-Fluticason-Mepha Nasal Spray, Suspension. This recall affects all retail-level distribution of the product. Healthcare professionals, pharmacists, quality managers, and regulatory specialists must take note and ensure compliance with the recall directive.
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What changed?
Swissmedic has identified a quality issue with batch number 100062289 of Azelastin-Fluticason-Mepha Nasal Spray, Suspension. The cause of the recall has not been disclosed publicly but warrants immediate action by stakeholders in the supply chain. As per regulatory obligations, all retail units of this specific batch must be removed.
Who is affected?
This announcement has direct implications for distributors, pharmacies, healthcare providers, and patients who rely on Azelastin-Fluticason-Mepha Nasal Spray for its intended usage as a combination nasal medication. Pharmacists are advised to check their inventory promptly for the recalled batch.
Furthermore, distributors and regulatory compliance officers must review their batch allocations. Patients using the spray should avoid products from this batch and consult their pharmacist or healthcare provider for guidance.
Actions required
To ensure safety and compliance:
- Pharmacies should immediately identify and segregate the recalled batch.
- Distributors must halt further deliveries of batch number 100062289 and confirm proper retrieval from retail outlets.
- Healthcare providers should notify relevant patients and recommend alternative treatment options.
- Regulatory teams in affected organizations must update their recall documentation and prepare verification reports.
Companies handling Azelastin-Fluticason-Mepha Nasal Spray must follow Swissmedic recall protocols and ensure adherence to national and EU regulatory requirements.
FAQ
Q1: What specific issues were found in this batch?
A1: Swissmedic has not disclosed the exact cause of the recall. Stakeholders should consult the official notice for further updates.
Q2: Can patients return the recalled batch to pharmacies?
A2: Yes, patients should contact their pharmacy for return instructions and alternative medications.
Q3: Is this recall limited to Switzerland?
A3: The recall announcement was made by Swissmedic, so it primarily applies to products distributed within Switzerland. Companies with international operations should verify their obligations.
Conclusion
Swissmedic’s announcement regarding batch 100062289 of Azelastin-Fluticason-Mepha Nasal Spray emphasizes the importance of maintaining safety, performance, and regulatory compliance in medical products. Stakeholders must act swiftly to ensure affected products are removed from circulation and alternative solutions are provided to consumers where necessary.
Disclaimer
This information is intended for medical and regulatory professionals. It does not constitute legal advice. Stakeholders should consult Swissmedic or legal counsel for specific obligations or compliance guidelines.
Swissmedic announcement
For full information about the Swissmedic announcement, see the link below.