Medicine recalls
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| The United Kingdom: Class 3 Medicines Recall: Zambon SpA, Emylif 50mg orodispersible film |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that Zambon SpA is recalling an affected batch of Emylif 50mg orodispersible film (riluzole) (batch number: C24QA104) as a precautionary measure due to out of specification results for unknown impurities during ongoing stability testing.
Ongoing stability testing identified out of specification results for unknown impurities at the 24-month stability timepoint for one batch of Emylif films. Emylif films were previously licensed with a 36-month shelf life.
The affected batch is being recalled as a precautionary measure before it reaches 24 months since the date of manufacture (C24QA104 would reach the 24-month timepoint on 30 April 2026).
Out of an abundance of caution, subsequent batches of Emylif 50mg orodispersible film, are labelled with an 18-month shelf life. This recall is at pharmacy and wholesaler level.
The product is indicated for the treatment of amyotrophic lateral sclerosis in adults.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/class-3-medicines-recall-zambon-spa-emylif-50mg-orodispersible-film-el-25-a-slash-47
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Tuesday, Nov 11, 2025
Issued at HKT 17:30
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