Received Apr 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MENB | MENINGOCOCCAL B (BEXSERO) | NOVARTIS VACCINES AND DIAGNOSTICS | UNK | DD72H | — |
administered doses of Bexsero to multiple patients after a temperature excursion out of range and out of the supported in house extended stability data; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received Men B NVS (Bexsero) (batch number DD72H, expiry date 30-NOV-2027) and (batch number 52N4S, expiry date 30-NOV-2027) for prophylaxis. On an unknown date, the patients received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patients experienced incorrect storage of drug (Verbatim: administered doses of Bexsero to multiple patients after a temperature excursion out of range and out of the supported in house extended stability data). 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: 27-MAR-2025 A pharmacist called to report that they administered Bexsero to multiple patients after a temperature excursion, which led to incorrect storage of drug. The reporter asked that it was a valid dose. The Bexsero vaccine was exposed to 67 degree fahrenheit for 67 hours 48 minutes. No prior excursions. The reporter asked that you have any stability data that exceeds 48 hours of stability for Bexsero. Medical information specialist (MIS) tried to get more details of the patients involved but pharmacist stated that he did not have more information of their initials, ages or gender.