Received Feb 11, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAP | DTAP (INFANRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | — | — |
Label is confusing/Potential medical error; This non-serious case was reported by a nurse via call center representative and described the occurrence of product label confusion 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 product label confusion (Verbatim: Label is confusing/Potential medical error). The outcome of the product label confusion 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: 02-FEB-2026 The nurse practitioner (NP) called and asked about the Infanrix age of administration. The NP explained that they had received two Infanrix purchases one on 09-APR-2025 and another on 18-AUG-202, and a colleague had mentioned that the vaccine box indicated an administration age from 6 weeks up to 7 years old. The product information (PI) was reviewed and informed the NP that the most recent Infanrix PI had been released in DEC-2024, and no updates had been received since then. The HCP confirmed that they had not administered Infanrix outside the PI age range (6 weeks to 6 years old). The MI (medical information) associates asked reporter if Infanrix vaccine should be administered to patients 6 weeks to 6 years of age, before the 7th birthday. Did they know if any patient received the vaccine outside of this age range. The HCP responded no. The HCP appeared to be confused due to the packaging (label was confusing). No PQC (product quality complaint) reported. The batch number was not provided upon follow up with the reporter.