PharmacovigilanceOfficial

AIFA warns of detaching stopper and seal on Caelyx 50 mg/25 mL vials

🇮🇹 AIFA · Fri 30 Oct 2026

Italy's medicines agency has published a DHPC after reports that the metal seal on certain Caelyx vials may not be firmly fixed, risking sterility and occupational exposure.

The Italian Medicines Agency (AIFA) published a Direct Healthcare Professional Communication on 30 October 2026 concerning a quality defect in CAELYX/DOXIL (pegylated liposomal doxorubicin), 50 mg/25 mL (2 mg/mL) solution for injection in single-dose vials.

According to the notice, cases of improper sealing of the aluminium seals have been reported in the batches listed in a table within the communication. The metal seal may not be securely fastened around the neck of the vial. Removing the flip-off cap can then cause the seal and the rubber stopper to come away, leaving the vial open.

An open vial compromises sterility, which could raise the risk of microbial contamination and infection. The notice also flags the possibility of unintended occupational exposure for staff handling the product. The summary on file describes the active substance as a cytotoxic agent.

The affected batches were distributed in Italy between 16 June 2026 and 28 August 2026. The communication refers users to Baxter for further guidance on defective vials. The batch numbers are given in the PDF attached to the AIFA notice and are not reproduced in the web text.

Healthcare professionals are asked to inspect each vial visually before use and again after removing the flip-off cap, looking for closure abnormalities, leaks or other signs that the container's integrity has been compromised. The aluminium seal and rubber stopper must stay in place. A vial with a defect should not be used; it should be withdrawn from use and Baxter contacted. Vials with no visible defects may be used as intended.

What it means for your team

  • Quality and supply teams should check stock against the batch table in the AIFA PDF, noting the Italian distribution window of 16 June to 28 August 2026.
  • Hospital pharmacy and oncology nursing procedures should include a visual check of each vial both before and after cap removal.
  • Defective vials should be quarantined and withdrawn, with Baxter contacted for guidance; the notice does not describe a wider recall.
  • Occupational safety and pharmacovigilance contacts should be aware of the sterility and cytotoxic-exposure risks linked to this defect.

Official source: AIFA ↗

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

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