Received Aug 19, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (RECOMBIVAX HB) | MERCK & CO. INC. | UNK | Unknown | — |
No symptoms reported; daughter who was administered an expired dose of RECOMBIVAXHB; This spontaneous report was received from a consumer (patient's parent) and refers to a newborn (0-day-old) female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On the day the patient was born, she was vaccinated with an expired hepatitis b vaccine (recombinant) (RECOMBIVAX HB INJ) suspension for injection at a dose of 0.5 mL, lot # was reported as 0100300064, however upon internal validation was determined to be invalid (route of administration, anatomical location and expiry date were not reported) for prophylaxis (Expired product administered). No symptoms were reported. Lot# is being requested and will be submitted if received.