Received Jul 1, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | 1 | 47XP4 | — |
A 23 years old female patient received a pediatric dose of Engerix-B; A 23 years old female patient received a pediatric dose of Engerix-B; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult use of a child product in a 23-year-old female patient who received HBV (Engerix B pediatric) (batch number 47XP4, expiry date 16-JUL-2026) for prophylaxis. On 23-JUN-2025, the patient received the 1st dose of Engerix B pediatric. On 23-JUN-2025, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: A 23 years old female patient received a pediatric dose of Engerix-B) and accidental underdose (Verbatim: A 23 years old female patient received a pediatric dose of Engerix-B). The outcome of the adult use of a child product and accidental underdose 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: 23-JUN-2025 On 23 June 2025 a practice manager called to report that they accidentally administered a pediatric dose of Engerix-B to a 23 years old female adult patient which led to adult use of a child product and Accidental underdose. This was the first dose of Engerix-B for the patient.