Received Dec 18, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | UNK | 9G523 | — |
Engerix-B administration after temperature excursion; 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 9G523, expiry date 20-MAY-2027) for prophylaxis. On 07-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 administration after temperature excursion). 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 (different lot numbers) that went through a temperature excursion and exceeded the below limit for stability were administered to the patient.; Sender's Comments: US-GSK-US2025160786:Same reporter/Different patient US-GSK-US2025160787:Same reporter/Different patient US-GSK-US2025160789:Same reporter/Different patient US-GSK-US2025160797:Same reporter/Different patient US-GSK-US2025160799:Same reporter/Different patient US-GSK-US2025160777:Same reporter/Different patient US-GSK-US2025160774:Same reporter/Different patient US-GSK-US2025160770:Same reporter/Different patient US-GSK-US2025160772:Same reporter/Different patient US-GSK-US2025160780:Same reporter/Different patient US-GSK-US2025160796:Same reporter/Different patient US-GSK-US2025160794:Same reporter/Different patient US-GSK-US2025160791:Same reporter/Different patient US-GSK-US2025160776:Same reporter/Different patient US-GSK-US2025160775:Same reporter/Different patient US-GSK-US2025160797:Same reporter/Different patient US-GSK-US2025160785:Same reporter/Different patient US-GSK-US2025160784:Same reporter/Different patient