Symptomtext
Product temperature excursion issue; This non-serious case was reported by a other health professional and described the occurrence of intercepted product storage error in a patient who received DTPa (Infanrix) (batch number A5573, expiry date 13-JUL-2025) for prophylaxis. Co-suspect products included DTPa-HBV-IPV (Pediarix) (batch number A32BB, expiry date 10-AUG-2025) for prophylaxis, DTPa-IPV (Kinrix) (batch number 7D2Y4, expiry date 22-AUG-2025) for prophylaxis, HAV (Havrix) (batch number 2YS34, expiry date 02-MAR-2025) for prophylaxis, HBV (Engerix B) (batch number EP724, expiry date 14-MAR-2025) for prophylaxis, Hib (Hiberix) (batch number G3453, expiry date 12-NOV-2024) for prophylaxis, Men ACWY-CRM NVS (Menveo) (batch number 9C2KP, expiry date 31-DEC-2024) for prophylaxis, Men B NVS (Bexsero) (batch number 2X955, expiry date 31-JAN-2026) for prophylaxis and Rota (Rotarix lyophilized formulation) (batch number Y4NG3, expiry date 03-OCT-2025) for prophylaxis. On an unknown date, the patient did not receive Infanrix .5 ml, Pediarix .5 ml, Kinrix .5 ml, Havrix .5 ml, Engerix B .5 ml, Hiberix .5 ml, Menveo .5 ml, Bexsero .5 ml and Rotarix lyophilized formulation .5 ml. On an unknown date, an unknown time after receiving Infanrix, Pediarix, Kinrix, Havrix, Engerix B, Hiberix, Menveo, Bexsero and Rotarix lyophilized formulation, the patient experienced intercepted product storage error (Verbatim: Product temperature excursion issue). The outcome of the intercepted product storage error was unknown. 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: 4-Oct-2023 The pharmacy technician reaching out to GlaxoSmithKline to inquired about a temperature excursion and to verify validation of stability. There were several GlaxoSmithKline vaccines that were affected. Excursion started on 30th September 2023 at 7:21 pm 8.0 C thru 1st October 2023 11:55 pm reaching 28.5C. The several GlaxoSmithKline vaccines had temperature excursion and all medications had been removed to recommended storage and quarantined, which led to intercepted product storage error.
