CAELYX (doxorubicin pegylated liposomal), 50 mg/25 mL (2 mg/mL) for injection, single-dose vial: Vial stopper and seal may detach during cap removal, potentially compromising sterility and resulting in unintended occupational exposure.

Summary

• There have been reports of improperly crimped aluminium vial seals in the CAELYX batches listed in the table below (the metal seal may not be securely fastened around the vial neck).
• Removal of the flip-off cap may cause the aluminium seal and rubber stopper to detach, leaving the vial open and compromising sterility. As a result, the risk of microbial contamination and infection may be increased.
• The affected batches were distributed in <Member State> from <dd/mm/yy> to <dd/mm/yy>. 
• Before use, and again after removing the flip-off cap, visually inspect each vial for closure abnormalities, leakage, or other signs of compromised container integrity. The aluminium seal and rubber stopper should remain in position.
• Do not use a vial with an observed defect. Remove it from use and contact Baxter for further guidance. 
• Vials with no visible defects may be used as intended.