Received Dec 16, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | UNK | 9G523 | — |
Engerix-B unstable after temperature excursion that went through a temperature excursion, exceeded the below limit for stability were administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of product storage error in a neonate male patient who received HBV (Engerix B) (batch number 9G523, expiry date 20-MAY-2027) for prophylaxis. On 03-DEC-2025, the patient received Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced product storage error (Verbatim: Engerix-B unstable after temperature excursion that went through a temperature excursion, exceeded the below limit for stability were administered). The outcome of the product storage error 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 This is 1 of the linked case from the same reporter.; Sender's Comments: US-GSK-US2025160799:SAME REPORTER GSK-US2025160791:SAME REPORTER US-GSK-US2025160793:SAME REPORTER US-GSK-US2025160796:SAME REPORTER US-GSK-US2025160787:Same reporter/Different patient US-GSK-US2025160770:SAME REPORTER US-GSK-US2025160797:SAME REPORTER US-GSK-US2025160773:Same reporter/Different patient US-GSK-US2025160789:SAME REPORTER GSK-US2025160785:Same reporter/Different patient US-GSK-US2025160784:Same reporter/Different patient US-GSK-US2025160786:Same reporter/Different patient GSK-US2025160774:Same reporter/Different patient