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| The United Kingdom: Class 2 Medicines Recall: Novartis Pharmaceuticals UK, Sandimmun Oral Solution (English only) |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that Novartis Pharmaceuticals UK is recalling one batch of Sandimmun Oral Solution (batch number: ADP326002) due to the presence of crystals in the solution. The crystals have been identified as the active substance (ciclosporin). The presence of crystals has been observed in some finished product packs marketed in other countries that share the same master batch as the United Kingdom batch above. Therefore, the above batch is recalled as a precautionary measure.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/class-2-medicines-recall-novartis-pharmaceuticals-uk-sandimmun-oral-solution-el-22-a-slash-40
In Hong Kong, Sandimmum Neoral Soln 100mg/ml (HK-38061) is a pharmaceutical product registered by Novartis Pharmaceuticals (HK) Limited (Novartis). The product is a prescription-only medicine. As confirmed with Novartis, the above batch has not been imported into Hong Kong.
Ends/Wednesday, Sep 21, 2022
Issued at HKT 15:30
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