Medicine recalls
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| The United Kingdom: Class 3 Medicines Recall: AstraZeneca UK Ltd., Fluenz Tetra nasal spray suspension |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that AstraZeneca UK Ltd. has informed the MHRA that, following routine stability analysis, the printed expiry date for 6 batches of Fluenz Tetra nasal spray suspension (reassortant influenza virus) (batch number: TH2127, TH2127B, TH3110, TH3110B, TJ2290, TJ2290B) is incorrect.
Due to the outcome of the ongoing analysis, the expiry dates for batches TH2127, TH2127B, TH3110, TH3110B, TJ2290 and TJ2290B need to be reduced by up to 5 days as a precautionary measure. The products may be safely administered up to the amended expiry date. For details of the amended expiry dates, please refer to the website in MHRA.
Healthcare professionals, specifically those involved in the administration of this vaccine should continue to use the vaccine as directed. The vaccines may be administered safely up to the amended expiry date. Batches administered before the amended expiry date are fully effective. Except for the amended expiry date, there are no other changes to the product information. Any stock that has not been administered before the amended expiry date should be quarantined. All quarantined stock should be returned.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/class-3-medicines-recall-astrazeneca-uk-ltd-dot-fluenz-tetra-nasal-spray-suspension-el-23-a-slash-39
In Hong Kong, there is one intranasal influenza vaccine, namely Flumist Quadrivalent Influenza Intranasal Vaccine (HK-65690), registered by AstraZeneca Hong Kong Ltd (AstraZeneca). The product is a prescription-only medicine. As confirmed with AstraZeneca, the affected batches have not been imported into Hong Kong.
Ends/Friday, Dec 1, 2023
Issued at HKT 15:00
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