Quality & complianceOfficial

SÚKL orders recall of Mynzepli pre-filled syringe batch down to healthcare facility level

🇨🇿 SÚKL · Thu 29 Oct 2026

The Czech regulator's quality defects department has told distributors and healthcare facilities to withdraw a specified batch of Mynzepli 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 Mynzepli is being recalled. The notice covers Mynzepli 40 mg/ml solution for injection in a pre-filled syringe, in packs of one 0.09 ml syringe.

The recall extends down to the level of healthcare facilities, meaning the withdrawal reaches beyond wholesalers to the sites where the product is held. SÚKL's quality defects department addressed the notice to distributors and healthcare facilities.

Patients are not asked to return their packs. The short public notice does not name the batch number in its text, and it gives no reason for the recall or any information on the nature of the defect. These details appear to be in an attached PDF communication dated 29 October 2026, which was not available for this report.

Recalls of this scope are a standard quality-defect measure. National authorities typically classify them by the level of the supply chain they reach, with wholesale, pharmacy and facility-level actions differing in reach and urgency.

What it means for your team

  • Distributors and healthcare facilities in the Czech Republic should check stock of Mynzepli 40 mg/ml pre-filled syringes against the batch identified in SÚKL's PDF notice and act on it.
  • Quality and supply-chain teams should consult the full SÚKL communication of 29 October 2026 for the batch number and any further instructions, as the web summary lacks them.
  • No patient-level return is requested, so the operational burden falls on the supply chain and healthcare sites rather than on patients.
  • Marketing authorisation holders with Mynzepli in other markets may wish to monitor whether other regulators take similar action; the source does not say whether they have.

Official source: SÚKL ↗

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

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