Received Jun 18, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAP | DTAP (INFANRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | 223Y9 | — |
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | UNK | — | — |
Infanrix and Engerix B have been used in patients; This non-serious case was reported by a nurse via call center representative and described the occurrence of product storage error in a male patient who received DTPa (Infanrix) (batch number 223Y9, expiry date 07-SEP-2026) for prophylaxis. Co-suspect products included HBV (Engerix B) for prophylaxis. On 27-MAY-2025, the patient received Infanrix. On an unknown date, the patient received Engerix B. On an unknown date, an unknown time after receiving Infanrix and Engerix B, the patient experienced product storage error (Verbatim: Infanrix and Engerix B have been used in patients). The outcome of the product storage error 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: Licensed Practical Nurse requested stability data for Havrix, Kinrix, Boostrix, Infanrix, Engerix B stored at 18.8 Celsius for 9 hours 20 minutes on 17 May 2025. The excursion was caught when doing monthly quality check. There were no prior excursions. The Infanrix vaccine and Engerix B vaccine have been used in patients which led to product storage error.