Report #2842622

Overview

Sex

Unknown

Age

Age unknown

State

CA

Recovered

Unknown

Vaccinated

—

Onset

—

Days to onset

—

Hospital days

—

Symptoms (1)

Symptom narrative

Havrix-Adult box has a sticker that says contains latex. PI inside this box states that the prefilled syringe is latex-free; Product complaint/ Pictures of this discrepancy-sticker on box, PI, product; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of product label confusion in an unspecified number of patients who received HAV (Havrix adult) (batch number 2345B, expiry date 02-FEB-2026) for prophylaxis. This case was associated with a product complaint. On an unknown date, the patient received Havrix adult. On an unknown date, an unknown time after receiving Havrix adult, the patient experienced product label confusion (Verbatim: Havrix-Adult box has a sticker that says contains latex. PI inside this box states that the prefilled syringe is latex-free) and pharmaceutical product complaint (Verbatim: Product complaint/ Pictures of this discrepancy-sticker on box, PI, product). The outcome of the product label confusion 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: 15-MAY-2025 The reporter was the HCP (health care professional). He was a medication safety pharmacist with 300 pharmacies. One of his pharmacists informed him that a box of Havrix-adult had a contains latex sticker on the front. The PI (product information) included inside this box reads: the tip cap and rubber plunger stopper of the prefilled syringe were not made with natural rubber latex. Pictures of this discrepancy (sticker on box, PI, product) would be sent to referencing the case number, which led to product label confusion and pharmaceutical product complaint. Confirmed that all operations were performed appropriately before defect was discovered. The Havrix-Adult box has a sticker that said contains latex. The PI inside this box stated that the prefilled syringe was latex-free. After partial use of the multi pack, the defect discovered. The product was administered. The box or carton and PI components was involved in the complaint Per QA Liaison, no return of suspect product or packaging was requested at this time. The reporter did not know how many doses have been used from the box. The customer 1 was the pharmacy that had the suspect product. For now, their information was here rather than in the HCP section as the reporter's email address needed to be noted for follow-up. Unspecified number of Havrix doses administered. There was a product complaint to report and complaint ID was reported.