Medicine recalls
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| The United Kingdom: Class 2 Medicines Recall: SANTEN Oy (trading as Santen UK Limited), IKERVIS 1 mg／ml eye drops, emulsion |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that SANTEN Oy (trading as Santen UK Limited) is recalling 2 batches of IKERVIS 1 mg/ml eye drops, emulsion (batch number: 1L49S, 1N80G), as a precautionary measure due to detection of particles/crystals of the active pharmaceutical ingredient ciclosporin. These particles have been detected following microscopic evaluation during stability monitoring. The company’s root cause investigation is ongoing.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/class-2-medicines-recall-santen-oy-trading-as-santen-uk-limited-ikervis-1-mg-slash-ml-eye-drops-emulsion-el-21-a-slash-22
In Hong Kong, Ikervis Eye Drops, Emulsion 1mg/ml (HK-65076) is a pharmaceutical product registered by Santen Pharmaceutical (Hong Kong) Limited (Santen), and is a prescription-only medicine. As confirmed with Santen, the affected batches have not been imported into Hong Kong. Related news was previously issued by Singapore Health Sciences Authority and Health Canada, and was posted on the Drug Office website on 27 Aug 2021 and 2 Sep 2021 respectively.
Ends/Thursday, Sep 16, 2021
Issued at HKT 16:00
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