Received Feb 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | 1 | 42B22 | — |
dose 1 given was a pediatric dose; dose 1 given was a pediatric dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 20-year-old female patient who received HBV (Engerix B pediatric) (batch number 42B22, expiry date 07-MAR-2026) for prophylaxis. On 25-JUL-2024, the patient received the 1st dose of Engerix B pediatric. On 25-JUL-2024, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: dose 1 given was a pediatric dose) and adult use of a child product (Verbatim: dose 1 given was a pediatric dose). The outcome of the underdose and adult use of a child product 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: 30-JAN-2025 The pharmacist reported that 21 year old female patient was in pharmacy requesting third dose of Engerix-B series. The first two doses were administered at another facility. Upon looking at the records, dose 1 was given was a pediatric dose which led to underdose and adult use of a child product. On 27th August 2024, dose 2 was given was an adult dose. The patient was 20 years old at the time of both doses. At the time of call, the pharmacist had not yet administered a third dose.