Summary

Théa Pharma S.A. is recalling batch 3X74 of Fixaprost eye drops (single-dose units) from the market in consultation with Swissmedic as a precautionary measure. The reason is a deviation detected at the manufacturer that could compromise sterility. To date, no quality defects have been demonstrated in the affected batch and no adverse drug reactions have been reported. Patients should not use packages with batch number 3X74 and should return them to their pharmacy or medical practice.

Persons

  • Théa Pharma S.A. (Manufacturer)
  • Swissmedic (Swiss Agency for Therapeutic Products)

Topics

  • Drug safety
  • Batch recall
  • Eye drops
  • Regulation

Clarus Lead

The recall is conducted preventively, without currently documented defects in the batch itself or patient harm. This underscores the regulatory precautionary measure regarding potential sterilization problems in manufacturing – a critical quality feature for sterile eye preparations.

Detailed Summary

Fixaprost is an eye drops preparation in single-dose units. The deviation was discovered not in the final product, but in the manufacturing process. Swissmedic and the manufacturer subsequently decided to proactively withdraw the affected batch 3X74 from the market, although control tests have not confirmed any actual impairment.

Patients who possess this batch are requested not to use the packages and to return them to their point of purchase (pharmacy or medical practice). Théa Pharma provides a contact point for inquiries.

Key Messages

  • Precautionary recall of a single batch without confirmed product defects
  • Manufacturing deviation could have compromised sterility
  • No previous reports of adverse effects
  • Affected patients should not use the preparation

Critical Questions

  1. Evidence: What specific manufacturing deviations were identified, and how was the potential sterility risk assessed?
  2. Data Quality: On what basis was it determined that controls "confirmed no impairment" if a sterility deviation was simultaneously present?
  3. Causality: How was the risk of actual contamination ruled out if the deviation was detected in the process?
  4. Feasibility: How many patients are affected, and how is it ensured that all packages of batch 3X74 are captured?
  5. Incentives: Does this recall follow regulatory minimum standards or go beyond them?

Source Directory

Primary Source: Recall Fixaprost Eye Drops – news.admin.ch

Regulatory Information:

Verification Status: ✓ 19.06.2026

This text was created with the support of an AI model. Editorial Responsibility: clarus.news | Fact-Check: 19.06.2026