Received Dec 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | UNK | 5F244 | — |
Engerix B unstable after temperature excursion administration; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a male patient who received HBV (Engerix B) (batch number 5F244, expiry date 09-SEP-2027) for prophylaxis. On 12-DEC-2025, the patient received Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced incorrect storage of drug (Verbatim: Engerix B unstable after temperature excursion administration). The outcome of the incorrect storage of drug was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK receipt date: 12-DEC-2025 A pharmacist reported that the Engerix B, had gone through a temperature excursion and had exceeded the lower limit for stability, and were administered to patient.; Sender's Comments: US-GSK-US2025160775:SAME REPORTER US-GSK-US2025160799:SAME REPORTER US-GSK-US2025160785:SAME REPORTER US-GSK-US2025160794:SAME REPORTER US-GSK-US2025160796:SAME REPORTER US-GSK-US2025160797:SAME REPORTER US-GSK-US2025160785:Same reporter/Different patient US-GSK-US2025160774:Same reporter/Different patient US-GSK-US2025160773: US-GSK-US2025160787:Same reporter/Different patient US-GSK-US2025160772:SAME REPORTER US-GSK-US2025160786:Same reporter/Different patient US-GSK-US2025160789:SAME REPORTER US-GSK-US2025160784:Same reporter/Different patient