Received Apr 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | 1 | LG749 | — |
Engerix-B- Pediatric dose administered to an adult patient; Engerix-B- Pediatric dose administered to an adult patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of adult use of a child product in a 59-year-old male patient who received HBV (Engerix B pediatric) (batch number LG749, expiry date 13-SEP-2026) for prophylaxis. On 11-APR-2025, the patient received the 1st dose of Engerix B pediatric. On 11-APR-2025, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: Engerix-B- Pediatric dose administered to an adult patient) and accidental underdose (Verbatim: Engerix-B- Pediatric dose administered to an adult patient). The outcome of the adult use of a child product and accidental underdose were not applicable. Additional Information: GSK Receipt Date: 11-APR-2025 Nurse reported that on 11th April 2025, an adult male patient had erroneously received the first dose of Engerix-B pediatric, which led to Adult use of a child product and Accidental underdose.