Symptomtext
administered act-hib that was reconstituted with expired diluent with no reported adverse event; administered act-hib that was reconstituted with expired diluent with no reported adverse event; Initial information received on 06-Feb-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a patient of an unknown age and gender who was administered Hib (Prp/T) Vaccine [Act-Hib] that was reconstituted with expired diluent with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received an unknown dose of suspect Hib (Prp/T) Vaccine Powder and solvent for solution for injection (lot number: UJ633AA, expiry date: 30-Jan-2023) [ACTHIB Diluent component (Expiry date: 30-Nov-2022, lot number: U7178AD) (with an unknown strength) via unknown route in unknown administration site for immunization. On an unknown date, the patient was administered Hib (Prp/T) Vaccine that was reconstituted with expired diluent with no reported adverse event (product preparation error) (poor quality product administered) (latency: unknown). It was reported, reporter did a monthly count on the product ACTHIB and noticed that the lot numbers and expiration dates are different from the box and the vials. Reporter is not sure which information she should be logging when the products are administered and would like further guidance and clarification. Caller transferred with question about ACTHIB expiration dates being different on the vials and on the box. Wanting to know which expiration dates they need to go by. Caller also stated that a patient was administered ACTHIB that was reconstituted with expired diluent. Caller does not have patients information or any further details of event. Action taken: not applicable. Outcome was Unknown for reported events This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.