Received Jun 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | UK023AA | OT |
Pentacel was given past the expiration date with no reported adeverse event; Initial information received on 15-May-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 6 months old female patient who was given Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] past the expiration date with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 03-May-2025, the patient received 0.5mL of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine, Suspension for injection (lot UK023AA, expiry date 30-APR-2025; strength not reported) for Immunization and was given past the expiration date with no reported adverse event (expired product administered) (latency same day). Reportedly, caller reported that the Pentacel was given to 3 different patients past the expiration date. The first injection occurred on 03-May-2025, the second on 12-May-2025 and the last injection was on 14-May-2025. 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.; Sender's Comments: US-SA-2025SA146684: US-SA-2025SA142769: