Reporte zur Charge U6567AA

Symptomtext

A patient received an expired diluent of ACT-HIB, no AE; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist. This case involves a patient (unknown demographics) who received an expired diluent HIB (PRP/T) VACCINE [ACT-HIB] (lot U6567AA and expiry date: 01-Mar-2021) via an unknown route in an unknown administration site for prophylactic vaccination on 13-Apr-2021 (expired product administered). The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided. The caller reported that the diluent was expired and the powder portion still within date, that the medication sent to the hospital floor from the pharmacy in a plastic bag out of the box and the patient had already been discharged from the hospital. Powder Portion: LOT: UJI66AA and expiry date: 31-May-2021 This was a case of actual medication error due to expired product administered (latency same day). At the time of reporting, no adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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.