Received Nov 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | UNK | — | — |
Inappropriate Dose Administered/ adult patients have been getting 2 pediatric doses of ENGERIX-B; patients have been getting 2 pediatric doses of ENGERIX-B to make one adult dose.; This non-serious case was reported by a nurse via call center representative and described the occurrence of adult use of a child product in an unspecified number of adult patients who received HBV (Engerix B pediatric) for prophylaxis. On an unknown date, the patient received Engerix B pediatric. On an unknown date, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: Inappropriate Dose Administered/ adult patients have been getting 2 pediatric doses of ENGERIX-B) and wrong technique in product usage process (Verbatim: patients have been getting 2 pediatric doses of ENGERIX-B to make one adult dose.). The outcome of the adult use of a child product and wrong technique in product usage process were not applicable. Additional Information: GSK receipt date 13- NOV- 2025 It was reported that the last 3 years, adult patients were getting 2 pediatric doses of Engerix-B to make one adult dose. The reporter asked If it was recommendation of GSK to withdraw the content of one PFS pediatric dose to mix it with another PFS pediatric dose and make it one shot? The reporter consented to follow up. The batch number was not provided upon follow- up with the reporter.