Publication #8176

Reference
Drug alert 20/2024
Name
Drug Alert Class 2 Drug Alert 20 2024 – Class 2 medicines recall – action within 48 hours – Desitin Pharma UK Ltd – Lamotrigine Desitin 10mg/ml suspension
Categories
Scottish Government Drug Alerts
Organization
Scottish Government Health and Social Care Directorates
Keywords
NHS Scotland Drugs Safety Risks Pharmaceutical Industry Medicines Recall
Description
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. 

Contact Name
Irene Fazakerley
Contact Address
Contact Phone

Created
2024-06-06 11:49:00


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