Received Jan 7, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RV1 | ROTAVIRUS (ROTARIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | J757K | — |
Dose administered after temperature excursion; 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 2-month-old male patient who received Rota (Rotarix liquid formulation) (batch number J757K, expiry date 05-DEC-2026) for prophylaxis. On 06-JAN-2026, the patient received Rotarix liquid formulation. On an unknown date, an unknown time after receiving Rotarix liquid formulation, the patient experienced incorrect storage of drug (Verbatim: Dose administered after temperature excursion). The outcome of the incorrect storage of drug was not applicable. Additional Information: GSK Receipt Date: 06-JAN-2026 The certified medical assistant mentioned that Rotarix (liquid) was exposed to a series of temperature excursions: 50.2 degree F for 3 hours, 51.8 degree F for 22 hours and 52 minutes, 53.2 degree F for 24 hours, 51.1 degree F for 24 hours and 52.7 degree F for 24 hours and 58 minutes. The reporter mentioned inadvertently administered one dose to a patient after all of these excursions happened.