Received Sep 22, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | UNK | UNK | — |
Product storage error; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in unspecified number of patients who received HBV (Engerix B) for prophylaxis. On an unknown date, the patient received Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced incorrect storage of drug (Verbatim: Product storage error). The outcome of the incorrect storage of drug was 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: 10-SEP-2025 The reporter requested for the stability data for Engerix-B stored at 46.4 Fahrenheit for 30 minutes. The excursion occurred on 08-AUG-2025, so reporter was sure that patients had been administered based on the date of the excursion. The lot and expiry dates were unknown.