Received Jun 16, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAP | DTAP (INFANRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | — | — |
INFANRIX was exposed to 5 excursions in 2024 and 2025 (4 of 5 were in 2024); 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 a patient who received DTPa (Infanrix) for prophylaxis. On an unknown date, the patient received Infanrix. On an unknown date, an unknown time after receiving Infanrix, the patient experienced incorrect storage of drug (Verbatim: INFANRIX was exposed to 5 excursions in 2024 and 2025 (4 of 5 were in 2024)). 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: 06-JUN-2025 Medical assistant reported that Infanrix was exposed to 5 excursions in 2024 and 2025 (4 of 5 were in 2024) which led to incorrect storage of drug. Highest temperature reached was 9.76C and they were above range for 1 hour and 15 minutes in total 75 minutes. No other excursions had occurred. The majority of all vaccines reported were administered to patients. healthcare professional did not have patient, product, other adverse event details available during call. This was 1 of 6 linked cases reported by same reporter, different suspect.; Sender's Comments: US-GSK-US2025071798:Same reporter, Different suspect US-GSK-US2025071804:Same reporter, Different suspect US-GSK-US2025071799:Same reporter, Different suspect US-GSK-US2025071800:Same reporter, Different suspect US-GSK-US2025071801:Same reporter, Different suspect US-GSK-US2025071802:Same reporter, Different suspect US-GSK-US2025071803:Same reporter, Different suspect US-GSK-US2025071805:Same reporter, Different suspect US-GSK-US2025071800:Same reporter, Different suspect