On October 8, 2025, Swissmedic issued an immediate recall for specified batches of ASS Cardio Spirig HC 100 mg film-coated tablets, extending to the retail level. The recall affects all batches listed in the notification and highlights concerns over potential quality deficiencies. Healthcare providers, pharmacies, and regulatory professionals should review this notice carefully to ensure compliance and minimize patient impact.
What changed?
Swissmedic’s official communication specifies a recall of predefined batches of ASS Cardio Spirig HC 100 mg film-coated tablets due to concerns identified during market surveillance. The affected products are being pulled back to retail outlets, ensuring that they are removed from circulation quickly and effectively.
This measure is part of Swissmedic’s commitment to safety and ensuring that pharmaceutical products meet stringent quality specifications.
Who is affected?
The recall primarily impacts pharmacies, drug distributors, and retail outlets that stock the specified batches. It is also significant for clinicians prescribing ASS Cardio Spirig HC, as they may need to re-evaluate dispensing options.
Quality teams in hospitals and regulatory compliance professionals must act swiftly to identify and quarantine these batches.
Regulatory details
Under Swiss regulations, recalls are classified to minimize risks to public health by removing potentially affected products. Swissmedic determined the recall level as “Retail Stage,” meaning wholesalers and pharmacies are the primary stakeholders involved in the withdrawal process. Manufacturers of ASS Cardio Spirig HC are expected to coordinate closely with supply chain entities to ensure full compliance.
Key obligations include:
- Identifying and segregating affected batches.
- Notifying downstream buyers and distributors.
- Submitting compliance reports to Swissmedic.
Failure to adhere to these requirements may result in formal enforcement actions, including fines or operational restrictions.
Manufacturer responsibility
The manufacturer stated that the reason for the recall is linked to specific batch quality risks, which were identified as part of routine control procedures. Transparency with regulatory bodies and healthcare practitioners remains key to addressing any residual concerns.
FAQs
Q1: Why are these batches being recalled?
A: The recall is due to quality deficiencies found in predefined batches, as noted by Swissmedic.
Q2: How does this recall affect patient care?
A: Healthcare providers should inform patients and adjust therapy plans as needed to avoid dispensing affected products.
Q3: What should pharmacies do?
A: Pharmacies need to segregate impacted batches immediately, notify the distributor, and comply with Swissmedic’s instructions.
Conclusion
The batch recall for ASS Cardio Spirig HC 100 mg film-coated tablets underlines Swissmedic’s role in enforcing quality standards. Healthcare professionals and regulatory teams must act promptly to ensure the affected batches are removed from retail points, protecting public health and maintaining compliance.
Disclaimer
This blog post is for informational purposes only and does not constitute legal advice. Healthcare providers and regulatory professionals should refer to the official Swissmedic notice for accurate guidance.
Swissmedic announcement link
For full information about the Swissmedic announcement, see the link below.