Quality & complianceOfficial

SÚKL recalls Mitomycin Accord batches down to healthcare-facility level in Czech Republic

🇨🇿 SÚKL · Thu 29 Oct 2026

The Czech regulator has told distributors and healthcare facilities to withdraw specified batches of Mitomycin Accord 20 mg powder for solution; patients need not return packs.

The Czech State Institute for Drug Control (SÚKL) announced on 29 October 2026 that specified batches of Mitomycin Accord 20 mg powder for solution for injection, infusion or intravesical use, in packs of five, are being recalled. The withdrawal extends down to healthcare-facility level.

The notice was issued by SÚKL's quality defects department and is addressed to distributors and healthcare facilities, which are expected to act on it. Patients are told they do not have to return any packs.

The web notice itself does not list the affected batch numbers or explain why the recall was ordered. Those details are in a separate PDF communication dated 29 October 2026 that accompanies the announcement and was not part of the text reviewed for this article. Anyone handling the product should consult that document directly for the batch list and any defect information.

What it means for your team

  • Czech distributors and healthcare facilities should check stock against the batch list in SÚKL's PDF communication of 29 October 2026 and follow its instructions.
  • Quality and supply teams at the marketing authorisation holder's side should confirm the scope of affected batches and the recall level with SÚKL's notice, as the web summary gives no batch numbers or reason.
  • Because the recall reaches healthcare-facility level but not patients, there is no patient-level return action to manage.

Official source: SÚKL ↗

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

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