Quality & complianceOfficial

SÚKL orders batch recall of Mynezpli pre-filled syringes down to healthcare-facility level

🇨🇿 SÚKL · Thu 29 Oct 2026

Czech regulator SÚKL has told distributors and healthcare facilities to withdraw a specified batch of Mynezpli 40 mg/ml solution for injection; patients need not return packs.

The State Institute for Drug Control (SÚKL) in the Czech Republic announced on 29 October 2026 that a batch of Mynezpli 40 mg/ml solution for injection in pre-filled syringes (1x0.09 ml) is being recalled. The notice was issued by the agency's Quality Defects Department.

The recall extends down to the level of healthcare facilities. Distributors and healthcare facilities are therefore expected to withdraw the affected batch from their stock, rather than the action stopping at wholesale level.

SÚKL states that patients are not required to return their packs. The agency's published notice, available as a PDF dated 29 October 2026, carries the details of the batch concerned.

The web announcement itself does not state the reason for the recall, the batch number in its text, or any risk assessment. Those details, if given, would be in the attached notice.

What it means for your team

  • Distributors and healthcare facilities supplied in the Czech Republic should check stock against the batch specified in the SÚKL notice and quarantine and withdraw it.
  • Quality and supply-chain teams should consult the full PDF notice for batch identification and return instructions, as the web summary gives no batch details or defect reason.
  • Because patients are not asked to return packs, the action is directed at the supply chain and care providers rather than at patients.

Official source: SÚKL ↗

Article written by VigiEye from the official source (SÚKL). AI-assisted; check the source before acting.

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