Received Aug 11, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | UNK | UNK | — |
Drug administered to patient of inappropriate age; Underdose; This non-serious case was reported by a physician via other manufacturer and described the occurrence of adult use of a child product in a 20-year-old patient who received HBV (Engerix B pediatric) for prophylaxis. On an unknown date, the patient received Engerix B pediatric .5 ml. On an unknown date, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: Drug administered to patient of inappropriate age) and underdose (Verbatim: Underdose). The outcome of the adult use of a child product and underdose were not applicable. Additional Information: GSK Receipt Date: 16-JUL-2025 Caller reported pediatric dose of Engerix was administered to a patient that was 20 years 4 months old, which led to adult use of child product and underdose. No other information provided. No additional adverse event or PQC reported.