Received Oct 20, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | 4 | UK093AB | OT |
they had a patient that was administered with ACTHIB that expired with no adverse event; Initial information received on 16-Oct-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a patient with unknown age and gender who was administered with Hib (Prp/T) Vaccine [Act-Hib] that expired with no adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 16-Oct-2025, the patient received an expired 0.5mL (dose 4( of suspect HIB (PRP/T) Vaccine, Powder and solvent for solution for injection (lot UK093AB, expiry date 30-Sep-2025, frequency once and strength standard) via intramuscular route in unknown administration site for Immunization with no adverse event (expired product administered) (latency same day). Reportedly, nurse mentioned that they had a patient that was administered with ACTHIB that expired on the last day of September and mentioned that she knew the dose need to be repeated but was confirming if there were any other precautions in this particular vaccine. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.