Quality & complianceOfficial

Baxter warns Caelyx vial seals may come loose, risking sterility and occupational exposure

🇩🇪 BfArM Rote-Hand-Brief · Fri 30 Oct 2026

Baxter Holding B.V. has reported incomplete aluminium crimping on Caelyx 50 mg/25 ml single-dose vials, which can leave the vial open when the cap is removed.

Baxter Holding B.V. has issued a Rote-Hand-Brief, published by BfArM on 30 October 2026, about cases of incomplete aluminium crimping on Caelyx 50 mg/25 ml (2 mg/ml) single-dose vials. The active substance is pegylated liposomal doxorubicin.

According to the letter, removing the flip-off cap from the crimp can cause the aluminium seal and the rubber stopper to come loose. The vial would then be open, and its sterility would be compromised.

Vials in which the defect is observed must not be used. The source text does not specify affected batches, quantities or the number of cases, and it does not describe a recall or a cause of the defect.

The short summary on file adds that the open vial could lead to unintended occupational exposure to the cytotoxic product. Details of the corrective measures are in the downloadable letter, a 399 KB PDF that BfArM notes is not accessible.

What it means for your team

  • Quality and pharmacy teams should check that staff handling Caelyx 50 mg/25 ml vials know not to use any vial showing the crimping defect.
  • Pharmacovigilance and quality-assurance teams should confirm that quality-defect reporting routes are in place for any vials found with a loose seal or stopper.
  • Occupational safety arrangements for handling cytotoxic products should be reviewed in light of the reported exposure risk.
  • Teams should read the full Rote-Hand-Brief PDF for batch details and any further instructions, as the BfArM summary gives none.

Official source: BfArM Rote-Hand-Brief ↗

Article written by VigiEye from the official source (BfArM Rote-Hand-Brief). AI-assisted; check the source before acting.

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