Product Information:
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.

Advice for healthcare professionals
Stop supplying the impacted batch immediately. Quarantine all remaining stock and return it to your supplier/MAH using your supplier’s approved process.

Patients should be advised not to stop their medication as this may cause seizures to start again or happen more often or last longer than before.

Click to view full text on MHRA website