Received Apr 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | UNK | D23D3 | — |
an adult dose of Engerix-B was administered to a pediatric patient; an adult dose of Engerix-B was administered to a pediatric patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult product administered to child in a 2-month-old female patient who received HBV (Engerix B adult) (batch number D23D3, expiry date 15-MAR-2025) for prophylaxis. On 14-FEB-2025, the patient received Engerix B adult. On 14-FEB-2025, an unknown time after receiving Engerix B adult, the patient experienced adult product administered to child (Verbatim: an adult dose of Engerix-B was administered to a pediatric patient) and overdose (Verbatim: an adult dose of Engerix-B was administered to a pediatric patient). The outcome of the adult product administered to child and overdose were not applicable. Additional Information: GSK Receipt Date : 14-APR-2025 Medical assistant called on April 18, 2025 to reported on February 14, 2025 an adult dose of Engerix-B was administered to a pediatric patient which led to adult product administered to child and overdose.