Received May 26, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| IPV | POLIO VIRUS, INACT. (IPOL) | SANOFI PASTEUR | UNK | — | — |
dose of IPOL being administered 48 days since opening the vial with no AE; Initial information received on 08-May-2026 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a patient of unknown age and unknown gender for whom a dose of IPV (VERO) [IPOL] being administered 48 days since opening the vial with no adverse event (AE). The patient's past medical history, past drugs, vaccination(s), family history, and concomitant medications were not provided. On an unknown date, the patient received an unknown dose of IPV (VERO) suspension for injection (batch/lot number: unknown, expiry date: Oct-2027) (strength: unknown) via unknown route in an unknown administration site for immunization; 48 days since opening the vial with no adverse event (AE) (Poor quality product administered, latency: same day). A pharmacist stated that they gave a patient a dose of IPOL but noticed that it had a 28-day beyond use date or expiration date. The vial was opened on 31-Mar-2026, and the date of administration would have been 48 days since opening it The pharmacist asked if the patient needed to be redosed. The pharmacist added that the solution inside was all clear and there was no cloudiness. The expiration date was October 2027. There was no off-label usage and there was no breach to the temperature. Information regarding batch number and expiration date corresponding to the one at time of event occurrence was requested. Action taken: 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 medication 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.
Comments: NONE