其 他 安 全 警 示
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| The United Kingdom: Class 4 defect information: Olmetec 20mg Film Coated Tablets (English Only) |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that Daiichi Sankyo UK Limited has informed there is an error on the blister foil of two batches of Olmetec 20mg Film-Coated Tablets (olmesartan medoxomil) (batch number: 293721 and 293820). An additional ingredient, hydrochlorothiazide, is listed under the product name. The wording on the carton and in the patient information leaflet is correct and the tablets in the foils are confirmed to be Olmetec 20mg Film-Coated tablets.
To ensure continuity of supply, affected stock is not being recalled. Distribution of the above batches will cease once unaffected stock is available. It is anticipated that new batches will be available during week commencing 24 Sep 2018.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/class-4-defect-information-olmetec-20mg-film-coated-tablets-mdr-12-08-18
In Hong Kong, Olmetec Tab 20mg (HK-53022) is a pharmaceutical product registered by Pfizer Corporation Hong Kong Limited (Pfizer), and is a prescription-only medicine. As confirmed with Pfizer, the affected batches have not been imported into Hong Kong.
Ends/Tuesday, Sep 4, 2018
Issued at HKT 15:00
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