Received Feb 19, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | UNK | UK169AB | OT |
ACT-HIB was reconstituted with the incorrect diluent and likely administered to a patient with no reported adverse event; Initial information received on 16-Feb-2026 regarding an unsolicited valid non-serious case received from a other health professional. This case involves involves patient of unknown demographics and HIB (PRP/T) VACCINE [ACT-HIB] was reconstituted with the incorrect diluent and likely administered to a patient with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, suspect HIB (PRP/T) VACCINE Powder and solvent for solution for injection of lot UK169AB and expiry date: 28-FEB-2026 via unknown route in unknown administration site for immunization was reconstituted with the incorrect diluent and likely administered to a patient with no reported adverse event (product preparation error) (latency: on same day). It was reported, the sterile diluent was in a 0.7 mL syringe. When MIS asked if the ACT-HIB was administered to a patient after it was reconstituted with the sterile water, the practice coordinator states that they are assuming that it was administered to a patient because the number of remaining ACT-HIB powder vials and diluent vials does not add up 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.