Received Aug 8, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEPA | HEP A (HAVRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | 42DM9 | — |
| HEPAB | HEP A + HEP B (TWINRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | 7XY23 | — |
Pediatric dose mistakenly administered to adult patient; Pediatric dose mistakenly administered to adult patient; late second dose for Twinrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a 48-year-old female patient who received HAB (Twinrix) (batch number 7XY23, expiry date 29-APR-2023) for prophylaxis. Co-suspect products included HAV (Havrix pediatric) (batch number 42DM9, expiry date 22-JAN-2027) for prophylaxis. Concomitant products included Hepatitis a vaccine inact, Hepatitis b vaccine rHBsAg (yeast) (Twinrix). On 30-MAR-2023, the patient received the 2nd dose of Twinrix. On 09-JUL-2025, the patient received Havrix pediatric. On 30-MAR-2023, an unknown time after receiving Twinrix and not applicable after receiving Havrix pediatric, the patient experienced drug dose administration interval too long (Verbatim: late second dose for Twinrix). On 09-JUL-2025, the patient experienced accidental underdose (Verbatim: Pediatric dose mistakenly administered to adult patient) and adult use of a child product (Verbatim: Pediatric dose mistakenly administered to adult patient). The outcome of the drug dose administration interval too long, accidental underdose and adult use of a child product 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: 10-JUL-2025 The Certified Medical Assistant explained that an adult patient had accidentally received a pediatric dose of Havrix in an attempt to complete the Hepatitis A series which led to, accidental underdose and adult use of a child product. The reporter stated that the patient had received 2nd dose of Twinrix was late which led to, drug dose administration interval too long. However, the patient had missed the third dose of Twinrix. To complete the Hepatitis B series, the patient had received a Hepatitis B vaccine from GlaxoSmithKline on October 10th, 2023, at another facility (brand name unknown, lot number 9JG23). The patient received Engerix B on 04th November 2023 (lot number 9JG23 with expiry date 10th February 2025). The case was transferred to a second-line Medical Information Specialist for further assistance. During the call, the Medical Assistant provided additional clarification and mentioned that they were unsure whether the patient had actually received the Twinrix doses.
TWINRIX