Quality & complianceOfficial

SÚKL flags Caelyx stopper and cap defect that may loosen during lid removal

🇨🇿 SÚKL · Fri 30 Oct 2026

The Czech regulator has published a marketing authorisation holder's letter on a quality defect in Caelyx pegylated liposomal 2 mg/ml, 1 x 25 ml, involving a stopper and closure that could come loose.

The Czech State Institute for Drug Control (SÚKL) published an information letter on 30 October 2026 concerning a quality defect in Caelyx pegylated liposomal 2 mg/ml concentrate for solution for infusion, in the 1 x 25 ml presentation. The notice came from the authority's quality defects department and is addressed to operators.

According to SÚKL, the marketing authorisation holder, Baxter Holding B.V. of Utrecht in the Netherlands, has reported that the stopper and closure may come loose when the cap is removed from the product.

The SÚKL web notice does not state which batches are affected, how many units are involved, or whether the company is recalling or quarantining stock. Nor does it describe any reported patient harm or set out specific actions for healthcare providers or wholesalers. Those details, if given, would be in the full letter, which SÚKL has attached to the notice as a PDF of about 296 kB.

As general context, information letters of this kind are a routine route for regulators and authorisation holders to alert supply-chain and healthcare operators to product quality problems and to any steps they should take.

What it means for your team

  • Quality and supply-chain teams handling Caelyx in the Czech Republic should read the full SÚKL PDF letter for batch details and any required actions.
  • The public notice only describes the defect as a possible loosening of the stopper and closure on cap removal; it gives no recall scope.
  • Pharmacovigilance teams may want to check whether any related complaints or reports have been received, using the details in the full letter.

Official source: SÚKL ↗

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

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