Medicine recalls
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| The United Kingdom: Class 2 Medicines Recall: Desitin Pharma UK Ltd, Lamotrigine Desitin 10mg/ml Oral Suspension |
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The Medicines and Healthcare products Regulatory Agency (MHRA) announces that Desitin Pharma UK Ltd is recalling all batches of Lamotrigine Desitin 10mg/ml Oral Suspension as a precautionary measure due to an out of specification observation in the appearance of samples during routine stability testing.
Desitin Pharma UK Ltd believe that this is a homogeneity issue with the batches manufactured. This issue means that there is the potential for some doses to have too little active ingredient (lamotrigine) in them and some doses to contain too much active ingredient. This could result in potential underdosing or overdosing. No such confirmed reports have been received to date. The root cause of this issue is under investigation, but based on the potential for a homogeneity issue, the product is being recalled as a precautionary measure.
Please note this is a Class 2 Patient, Pharmacy and Wholesaler level recall. For details of the affected batch numbers, please refer to the website in MHRA.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/class-2-medicines-recall-desitin-pharma-uk-ltd-lamotrigine-desitin-10mg-slash-ml-oral-suspension-el-24-a-slash-20
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Friday, Jun 7, 2024
Issued at HKT 15:30
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