Received Jun 13, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | 1 | 9452S | — |
accidentally administered a pediatric dose of Engerix-B to an adult patient; accidentally administered a pediatric dose of Engerix-B 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 37-year-old female patient who received HBV (Engerix B pediatric) (batch number 9452S, expiry date 14-SEP-2025) for prophylaxis. On 02-JUN-2025, the patient received the 1st dose of Engerix B pediatric. On 02-JUN-2025, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: accidentally administered a pediatric dose of Engerix-B to an adult patient) and accidental underdose (Verbatim: accidentally administered a pediatric dose of Engerix-B to an adult patient). 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: 06-JUN-2025 Registered Nurse called to report that they accidentally administered a pediatric dose of Engerix-B to an adult female patient (37 years old), which led to adult use of a child product and accidental underdose.