Medicine recalls
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| The United Kingdom: Class 2 Medicines Recall: SANTEN Oy (trading as Santen UK Limited) and parallel distributor, IKERVIS 1 mg／ml eye drops, emulsion and VERKAZIA 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) and parallel distributor (Orifarm A/S) are recalling the following batches of products 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 affected products are:
SANTEN Oy (trading as Santen UK Limited)
- IKERVIS 1 mg/ml eye drops, emulsion (batch number: 8K38Q, 4L41F, 8L28C)
- VERKAZIA 1 mg/ml eye drops, emulsion (batch number: 1L14P, 4L40H, 6L04J)
Orifarm A/S
- IKERVIS 1 mg/ml eye drops, emulsion (batch number: 6L03F)
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-and-parallel-distributor-ikervis-1-mg-slash-ml-eye-drops-emulsion-and-verkazia-1-mg-slash-ml-eye-drops-emulsion-el-21-a-slash-30
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 above affected batches have 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 16 Nov 2021.
Ends/Friday, Nov 19, 2021
Issued at HKT 15:00
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