Quality & complianceOfficial

SÚKL circulates information letter on Respreeza vial closure defect

🇨🇿 SÚKL · Thu 05 Nov 2026

Czech regulator SÚKL has published a marketing authorisation holder's letter to operators on a vial closure defect affecting CSL Behring's Respreeza 1000 mg.

The State Institute for Drug Control (SÚKL) in the Czech Republic published an information letter on 5 November 2026 concerning a quality defect in Respreeza. The notice came from its quality defects department and is addressed to operators in the supply chain.

The marketing authorisation holder, CSL Behring GmbH of Marburg, Germany, reported a defect in the closure of the injection vial. The product concerned is Respreeza 1000 mg powder and solvent for solution for infusion, supplied as a 1+1x20 ml pack with adapter and filter.

The web notice itself gives only this brief description. It does not set out affected batches, the risk assessment or any measures operators are expected to take. Those details are contained in the attached letter, a PDF of about 342 kB.

As general context, information letters of this kind are used by regulators and marketing authorisation holders to pass on product quality defect details and any required actions to pharmacies, distributors and other operators.

What it means for your team

  • Quality and supply-chain teams handling Respreeza in the Czech Republic should read the full PDF letter for batch details and instructions, as the web notice does not state them.
  • Distributors and pharmacies should check whether they hold the 1000 mg 1+1x20 ml pack with adapter and filter.
  • Regulatory affairs teams at other companies and in other markets may wish to check whether the holder has issued comparable communications elsewhere.

Official source: SÚKL ↗

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

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