Received Jul 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | UNK | — | — |
Engerix-B pediatric dose administered to an adult; Underdose; 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 33-year-old male patient who received HBV (Engerix B pediatric) for prophylaxis. On 01-JUL-2025, the patient received Engerix B pediatric. On 01-JUL-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) and underdose (Verbatim: Underdose). The outcome of the adult use of a child product and underdose were not applicable. Additional Information: GSK Receipt Date: 16-JUL-2025 Pharmacist who covered several health facilities, reported that in another a 33 year-old patient received Engerix-B pediatric dose which led to underdose and adult use of a child product. Lot number or expiration date unavailable at the moment of the call.