Caelyx vials in batch 5I021E may open when the cap is removed
The French drug safety agency ANSM has warned that some batches of Caelyx, a liposomal cancer drug given by infusion, may have a badly fitted aluminium cap. When the removable cap is taken off, the cap and rubber stopper can come loose and leave the vial open, which raises the risk of microbial contamination. Batch 5I021E, distributed in France between 5 March and 6 May 2026, is named in the notice, and manufacturer Baxter should be contacted for any damaged vial.
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What does it mean?
If you or someone you know receives Caelyx from a hospital, check the vial's metal cap and rubber stopper before and after removing the plastic cap. If either has loosened, do not use that vial, because it may no longer be sterile.
Who is affected?
Hospitals, pharmacists, nurses and doctors who handle Caelyx vials, especially those from batch 5I021E.