Received Mar 14, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | UNK | — | — |
| MENB | MENINGOCOCCAL B (BEXSERO) | NOVARTIS VACCINES AND DIAGNOSTICS | UNK | — | — |
requests stability data for Bexsero, Engerix-B stored at 33.5F for 15hours; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect product storage in unspecified number of patients who received Men B NVS (Bexsero) for prophylaxis. Co-suspect products included HBV (Engerix B) for prophylaxis. On an unknown date, the patient received Bexsero and Engerix B. On an unknown date, an unknown time after receiving Bexsero and Engerix B, the patient experienced product storage error (Verbatim: requests stability data for Bexsero, Engerix-B stored at 33.5F for 15hours). The outcome of the product storage error 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: 06-MAR-2025 A Licensed Practical Nurse requested stability data for Bexsero and Engerix B stored at 33.5 Fahrenheit for 15 hours which led to incorrect storage of drug. The reporter reported no prior excursions and no signs of freezing or slushing The unknown number of patients involved as excursion occurred on 05 December 2024.