PharmacovigilanceOfficial

Slovenia warns of crimped-seal defect in Caelyx liposomal doxorubicin vials; one batch affected

🇸🇮 JAZMP · Mon 02 Nov 2026

JAZMP has published a DHPC urging careful visual inspection of Caelyx 2 mg/ml vials after some batches were found with incorrectly crimped aluminium seals.

Slovenia's medicines agency, JAZMP, has published a Direct Healthcare Professional Communication (DHPC) on Caelyx pegylated liposomal 2 mg/ml concentrate for solution for infusion (doxorubicin). It asks healthcare professionals to inspect vials carefully before use.

The concern is that the aluminium seals on the vials of some batches were not crimped correctly. According to the notice, the stopper and the seal may separate while the cap is being removed.

JAZMP says such separation could compromise the sterility of the medicine and could lead to unintentional occupational exposure for the staff handling it.

One potentially affected batch is on the Slovenian market, number 5J023D. The agency's notice, which links to the full DHPC, does not set out further actions in the text available to us, so readers should consult the DHPC itself.

A DHPC is a communication sent by a marketing authorisation holder, in agreement with the competent authority, to inform prescribers and other healthcare professionals of new safety or quality information.

What it means for your team

  • Quality and supply teams should check whether batch 5J023D, or any other batch named in the full DHPC, is held in their distribution chain or at their sites.
  • Hospital pharmacy and oncology nursing staff should be reminded to inspect the vial closure visually before removing the cap, as the notice advises.
  • Pharmacovigilance and occupational-safety teams should note the risk of sterility loss and accidental operator exposure when handling cytotoxic products.
  • Teams should read the full DHPC for the required actions and the list of affected batches, since the JAZMP summary is brief.

Official source: JAZMP ↗

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

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