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 one batch of IKERVIS 1 mg/ml eye drops, emulsion (batch number: 4N46E) 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.
Following new investigations, SANTEN Oy is recalling the above batch additional to those recalled on 15 Sep 2021 and 18 Nov 2021.
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-22-a-slash-01
In Hong Kong, Ikervis Eye Drops, Emulsion 1mg/ml (HK-65076) is a pharmaceutical product registered by Santen Pharmaceutical (Hong Kong) Limited (Santen). The product is a prescription-only medicine. As confirmed with Santen, the above affected batch has not been imported into Hong Kong. Related news was previously issued by various overseas drug regulatory authorities, and was posted on the Drug Office website since 27 Aug 2021, with the latest update posted on 11 Jan 2022.
Ends/Thursday, Jan 20, 2022
Issued at HKT 16:00
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