Medicine recalls
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| The United Kingdom: Class 3 Medicines Recall: Lupin Healthcare (UK) Limited, Simvador 10mg, 20mg and 40mg Tablets |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that Lupin Healthcare (UK) Limited has informed MHRA that certain batches of the following simvastatin products (also distributed by Discovery Pharmaceuticals/Dexcel Pharma Limited) have been packaged with a version of patient information leaflet (PIL) that does not include the most up to date safety information. The affected products are:
- Simvador 10mg Tablets (batch number: G902211)
- Simvador 20mg Tablets (batch number: G902283)
- Simvador 40mg Tablets (batch number: G803251, G803252, G803253, G803254, G802355, G902245, G902242, G902243 and G902241)
There are no concerns with the quality, safety and efficacy of the product. However, these affected batches are being recalled due to concerns around the omission of the safety information.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/class-3-medicines-recall-lupin-healthcare-uk-limited-simvador-10mg-20mg-and-40mg-tablets-el-20-a-57
In Hong Kong, the above products are not registered pharmaceutical products.
Ends/Friday, Dec 4, 2020
Issued at HKT 16:00
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