Received Jul 1, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEPA | HEP A (HAVRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | 42DM9 | — |
Havrix plus Administration after temperature excursion; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a 18-month-old female patient who received HAV (Havrix) (batch number 42DM9, expiry date 22-JAN-2027) for prophylaxis. On 18-JUN-2025, the patient received Havrix. On an unknown date, an unknown time after receiving Havrix, the patient experienced incorrect storage of drug (Verbatim: Havrix plus Administration after temperature excursion). 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: 24-JUN-2025 Pharmacist called to verify if doses of vaccines that have been exposed to low temperatures should be repeated. Havrix Temperature 26.5 degree Fahrenheit which led to incorrect storage of drug. This case has been linked to US2025079380 reported by the same reporter.; Sender's Comments: US-GSK-US2025079380:Same reporter different patient