Medicine recalls
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| The United Kingdom: Class 3 Medicines Recall: Syri Limited, T/A SyriMed, Baclofen 10mg/5ml Oral Solution |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that Syri Limited, T/A SyriMed is recalling one batch of Baclofen 10mg/5ml Oral Solution (batch number: EBB23004A1) as a precautionary measure due to crystallisation observed over time in the oral solution. Testing results show that the assay of the filtered oral solution does not comply with the licensed specification of the product. The recall is at pharmacy and wholesaler level.
The product is indicated for the relief of spasticity of voluntary muscle resulting from such disorders as: multiple sclerosis, other spinal lesions, e.g. tumours of the spinal cord, syringomyelia, motor neurone disease, transverse myelitis, traumatic partial section of the cord.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/class-3-medicines-recall-syri-limited-t-slash-a-syrimed-baclofen-10mg-slash-5ml-oral-solution-el-24-a-slash-56
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Tuesday, Nov 26, 2024
Issued at HKT 15:00
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