Received Aug 18, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEPA | HEP A (HAVRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | 4T93R | — |
received the Havrix, the adult dose instead of the pediatric dose; Unapproved age; This non-serious case was reported by a other health professional via call center representative and described the occurrence of overdose in a 13-year-old female patient who received HAV (Havrix 1440 adult) (batch number 4T93R, expiry date 11-JUL-2026) for prophylaxis. Previously administered products included Havrix (1st dose received on 18-SEP-2024). On 11-AUG-2025, the patient received the 2nd dose of Havrix 1440 adult. On 11-AUG-2025, an unknown time after receiving Havrix 1440 adult, the patient experienced overdose (Verbatim: received the Havrix, the adult dose instead of the pediatric dose) and adult product administered to child (Verbatim: Unapproved age). The outcome of the overdose and adult product administered to child 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: 11-AUG-2025 The medical assistant reported they had a patient who received the Havrix, the adult dose instead of the pediatric dose today on the day of reporting, which led to an overdose and adult product administered to child. The reporter wanted to know if GlaxoSmithKline have any recommendations.