Received Feb 18, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAP | DTAP (INFANRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | 5st5m | — |
package information confusing and incorrectly stated as to what is printed in the PI.; Product complaint; This non-serious case was reported by a consumer via call center representative and described the occurrence of product label issue in a patient who received DTPa (Infanrix) (batch number 5st5m) for prophylaxis. This case was associated with a product complaint. On an unknown date, the patient received Infanrix. On an unknown date, an unknown time after receiving Infanrix, the patient experienced product label issue (Verbatim: package information confusing and incorrectly stated as to what is printed in the PI.) and pharmaceutical product complaint (Verbatim: Product complaint). The outcome of the product label issue and pharmaceutical product complaint were 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: 16-FEB-2026 Health care professional states the package denotes use from 6 weeks to 7 years of age however the package insert states 6 weeks through 6 years (prior to the seventh birthday). Health care professional states no doses were missed or given outside age range stated in package insert.