Received Jun 13, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | UNK | 4D333 | — |
Engerix-B stored at 18.8 celsius 9hrs 20mins on May, 17, 2025; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 1-month-old female patient who received HBV (Engerix B) (batch number 4D333, expiry date 14-AUG-2026) for prophylaxis. On 19-MAY-2025, the patient received Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced incorrect storage of drug (Verbatim: Engerix-B stored at 18.8 celsius 9hrs 20mins on May, 17, 2025). 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: 11-JUN-2025 Nurse requested stability data for Havrix, Kinrix, Boostrix, Infanrix, Engerix-B stored at 18.8 Celsius for 9 hours 20 minutes on 17th May 2025 which led to incorrect storage of drug. Excursion caught when doing monthly quality check. No prior excursions. Engerix-B had been used in patients.