Received Dec 22, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | 2 | 47XP4 | — |
Pediatric dose to an adult patient; Pediatric dose to an adult patient; Late 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of adult use of a child product in a 45-year-old male patient who received HBV (Engerix B pediatric) (batch number 47XP4) for prophylaxis. On 11-DEC-2025, the patient received the 2nd dose of Engerix B pediatric. On 11-DEC-2025, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: Pediatric dose to an adult patient), underdose (Verbatim: Pediatric dose to an adult patient) and drug dose administration interval too long (Verbatim: Late 2nd dose). The outcome of the adult use of a child product, underdose and drug dose administration interval too long were 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 Healthcare professional (HCP) informed that the patient was due for the 2nd dose and the patient received a pediatric dose. During the call, the HCP informed that this was about Engerix-B.