Received Nov 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | 3 | — | — |
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | 2 | Y5AJ9 | — |
patient received his third dose late; Engerix-B pediatric 2nd dose given to adult; Engerix-B pediatric 2nd dose given to adult; patient received his second late; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of adult use of a child product in a 52-year-old male patient who received HBV (Engerix B pediatric) (batch number Y5AJ9, expiry date 03-MAR-2025) for prophylaxis. Co-suspect products included HBV (Engerix B adult) for prophylaxis. Previously administered products included Engerix B (first dose was an adult dose given on 03 Oct 2024). On 03-JAN-2025, the patient received the 2nd dose of Engerix B pediatric. On 01-AUG-2025, the patient received the 3rd dose of Engerix B adult. On 03-JAN-2025, an unknown time after receiving Engerix B pediatric and not applicable after receiving Engerix B adult, the patient experienced adult use of a child product (Verbatim: Engerix-B pediatric 2nd dose given to adult), underdose (Verbatim: Engerix-B pediatric 2nd dose given to adult) and drug dose administration interval too long (Verbatim: patient received his second late). On 01-AUG-2025, the patient experienced drug dose administration interval too long (Verbatim: patient received his third dose late). The outcome of the adult use of a child product, underdose, drug dose administration interval too long and drug dose administration interval too long were not applicable. Additional Information: GSK Receipt Date: 01-AUG-2025 Pharmacist called first dose was an adult dose given on 03 Oct 2024. An adult patient received the pediatric dose of Engerix-B as the second dose in their schedule on 03 Jan 2025 which led to Drug dose administration interval too long. Second dose was the inadvertently pediatric on 03 January 2025 which led to Adult use of a child product and underdose. Third dose was an adult dose given today, 01 August 2025 which led to Drug dose administration interval too long.