Executive Summary
Labatec Pharma SA, in coordination with Swissmedic, is precautionarily recalling batch 55234 of Mycostatin oral suspension (100,000 I.U./ml) from the market. The measure extends to the patient level. No adverse drug reactions related to the deviation have been reported to date. Patients are urged to return any remaining products from this batch to their pharmacy and consult medical professionals with questions regarding further treatment.
Parties Involved
- Labatec Pharma SA (Manufacturer)
- Swissmedic (Swiss Medicines Institute)
Topics
- Drug Safety
- Batch Recall
- Quality Control
Clarus Lead
The recall is initiated as a purely precautionary measure, without any documented cases of harm – a standard safety protocol of the Swiss pharmaceutical market. The affected batch is precisely identified, which enables targeted retrieval and excludes confusion with other batches.
Detailed Summary
Mycostatin is an antifungal agent (fungicide) in liquid form for oral administration. The suspension is offered in a concentration of 100,000 international units per milliliter. The affected batch bears the number 55234.
The recall is based on a quality deviation, the specific nature of which is not specified in the notice. Despite the deviation, neither the authorities nor the manufacturer have received reports of adverse effects attributable to this batch. This suggests that the identified problem was detected preventively before it could cause patient harm.
Patients who possess or use this batch should arrange for its return to pharmacies. Medical professionals including physicians, pharmacists, and other specialists are available for consultation regarding continuation of treatment. Labatec Pharma SA also provides a direct contact channel via email and website.
Key Messages
- Batch 55234 of Mycostatin suspension is being recalled precautionarily
- No known patient harm documented to date
- Return to pharmacies required; medical consultation recommended for therapy continuation
Critical Questions
Evidence/Data Quality: What specific quality deviation was identified in batch 55234, and by which testing procedures was it detected?
Conflicts of Interest: Was the recall initiated voluntarily by the manufacturer or ordered by Swissmedic, and are there documented quality problems with previous batches of the same product?
Causality: Is the recall based on a technical manufacturing defect, storage damage, or packaging deficiency – and how was it ruled out that the deviation has no health effects?
Feasibility: How is it ensured that patients receive this information, and are there alternative therapeutic options available during the recall phase?
References
Primary Source: Labatec Pharma SA / Swissmedic – Mycostatin Suspension Batch Recall – https://www.news.admin.ch/de/newnsb/h7EEWmVfnYYOc83_8eghb
Verification Status: ✓ 25.06.2026
This text was created with the support of an AI model. Editorial Responsibility: clarus.news | Fact-Check: 25.06.2026