Received Nov 3, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | UNK | AZ4TN | — |
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | 1 | — | — |
Medication error/ Inappropriate dose administered; Medication error/ Inappropriate dose administered; Medication error/ Inappropriate dose administered; Medication error/ Inappropriate dose administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult use of a child product in a adult male patient who received HBV (Engerix B pediatric) (batch number AZ4TN, expiry date 25-JAN-2027) for prophylaxis. Co-suspect products included HBV (Engerix B pediatric) for prophylaxis. On 21-OCT-2025, the patient received Engerix B pediatric. On an unknown date, the patient received the 1st dose of Engerix B pediatric. On 21-OCT-2025, an unknown time after receiving Engerix B pediatric and not applicable after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: Medication error/ Inappropriate dose administered) and underdose (Verbatim: Medication error/ Inappropriate dose administered). On an unknown date, the patient experienced adult use of a child product (Verbatim: Medication error/ Inappropriate dose administered) and underdose (Verbatim: Medication error/ Inappropriate dose administered). The outcome of the adult use of a child product, underdose, adult use of a child product and 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: 22-OCT-2025 The health care professional reported that a patient had been administered two pediatric doses of Engerix-B (10 mcgs). The date for the first dose was unknown, and the date of the 2nd dose administered was 21-OCT-2025. No further details provided.