Quality & complianceOfficial

AIFA flags Caelyx/Doxil vial defect that could leave cytotoxic product exposed and non-sterile

🇮🇹 AIFA · Fri 30 Oct 2026

Italy's medicines agency has published a quality DHPC after reports that the aluminium ferrule on some Caelyx/Doxil 50 mg/25 mL vials was improperly sealed, risking sterility and operator exposure.

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

According to the notice, there have been reports of improper sealing of the aluminium ferrules on vials from the batches listed in a table in the communication. The metal ferrule may not be firmly fixed around the vial neck. Removing the flip-off cap can then pull off the ferrule and the rubber stopper, leaving the vial open.

An open vial compromises sterility and could raise the risk of microbial contamination and infection. The defect could also lead to unintended occupational exposure for staff handling the product, which is a cytotoxic agent. The affected batches were distributed in Italy between 16 June 2026 and 28 August 2026.

Healthcare professionals are asked to inspect each vial visually before use and again after removing the flip-off cap, checking for closure anomalies, leaks or other signs that container integrity has been compromised. The aluminium ferrule and rubber stopper must stay in place. A defective vial should not be used; it should be taken out of use and Baxter contacted for further guidance. Vials with no visible defect can be used as intended.

What it means for your team

  • Quality and pharmacy teams should check the batch table in the full AIFA communication against stock received in Italy between 16 June and 28 August 2026.
  • Hospital staff should inspect vials twice, before use and after removing the flip-off cap, and quarantine any vial with a closure defect and contact Baxter.
  • Occupational safety and QA functions should note the potential for unintended exposure to a cytotoxic agent when a ferrule and stopper detach.
  • Vials without visible defects can still be used as intended, according to the notice.

Official source: AIFA ↗

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

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