Received Apr 8, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAP | DTAP (INFANRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | Y97N7 | — |
| DTAPIPV | DTAP + IPV (KINRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | 42Y93 | — |
| FLU3 | INFLUENZA (SEASONAL) (FLULAVAL) | GLAXOSMITHKLINE BIOLOGICALS | UNK | DJ22N | — |
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | UNK | — | — |
| HEPA | HEP A (HAVRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | A3X2K | — |
| HIBV | HIB (HIBERIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | 3A2KF | — |
| MENB | MENINGOCOCCAL B (BEXSERO) | NOVARTIS VACCINES AND DIAGNOSTICS | UNK | ZK9D4 | — |
| MMR | MEASLES + MUMPS + RUBELLA (PRIORIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | KH2BB | — |
| MNQ | MENINGOCOCCAL CONJUGATE (MENVEO) | NOVARTIS VACCINES AND DIAGNOSTICS | UNK | X4T99 | — |
| RV1 | ROTAVIRUS (ROTARIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | 7E9Y2 | — |
| TDAP | TDAP (BOOSTRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | 5YB5G | — |
Improper storage error/stored at 47.5F for 36 mins 11secs prior above temperature excursions; 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 an unspecified number of patients who received HAV (Havrix) (batch number A3X2K, expiry date 07-SEP-2026) for prophylaxis. Co-suspect products included Rota (Rotarix liquid formulation) (batch number 7E9Y2, expiry date 30-MAY-2026) for prophylaxis, Men B NVS (Bexsero) (batch number ZK9D4, expiry date 30-APR-2027) and (batch number B4J4B, expiry date 31-OCT-2027) for prophylaxis, DTPa (Reduced antigen) (Boostrix) (batch number 5YB5G, expiry date 09-OCT-2026) for prophylaxis, DTPa-IPV (Kinrix) (batch number 42Y93, expiry date 05-JUN-2026) for prophylaxis, DTPa (Infanrix) (batch number Y97N7, expiry date 31-AUG-2026) for prophylaxis, MMR (Priorix) (batch number KH2BB, expiry date 01-JAN-2026) for prophylaxis, Flu Seasonal TIV Quebec (FluLaval 2024-2025 season) (batch number DJ22N, expiry date 13-JUN-2025) for prophylaxis, Men ACWY-CRM NVS (Menveo) (batch number X4T99, expiry date 30-SEP-2025) for prophylaxis, Hib (Hiberix) (batch number 3A2KF, expiry date 14-JUL-2026) for prophylaxis and HBV (Engerix B) for prophylaxis. On an unknown date, the patient received Havrix, Rotarix liquid formulation and Bexsero. On an unknown date, the patient received Boostrix, Kinrix, Infanrix, Priorix, FluLaval 2024-2025 season, Menveo, Hiberix and Engerix B. On an unknown date, an unknown time after receiving Havrix, Rotarix liquid formulation, Bexsero, Boostrix, Kinrix, Infanrix, Priorix, FluLaval 2024-2025 season, Menveo, Hiberix and Engerix B, the patient experienced incorrect storage of drug (Verbatim: Improper storage error/stored at 47.5F for 36 mins 11secs prior above temperature excursions). 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: 27-MAR-2025 The reporter reported the stability data for an excursion than occurred on 13th March 2025 for Bexsero, Menveo (1-vial), Flulaval, Havrix, Kinrix, Boostrix, Infanrix, Engerix-B, Hiberix, Rotarix (liq), Priorix stored at 47.5F for 36 mins 11secs which led to, incorrect storage of drug. The reporter stated the vaccines prior above temperature excursions, called into GlaxoSmithKline, details not provided. The reporter mentioned the several vaccines were used in patients prior to called to GlaxoSmithKline.