Safety Alerts & Recalls

What does this mean?

This recall for Lamictal 50 mg, 100 mg, and 200 mg tablets was issued at the wholesale and pharmacy level only. The MHRA and companies involved have determined that there is no specific evidence to suggest that the medicines are not safe for patient use. People should continue to take their medication as directed. If you use Lamictal and are concerned, you should follow up with your doctor or pharmacist.

Recall Lamictal: Safety Warnings Not Included in Patient Information Leaflet

P.I.E. Pharma Limited is recalling unused stock from select batches of Lamictal 50 mg, 100 mg, and 200 mg tablets because the patient information leaflet (PIL) has not been updated to include mandatory safety warnings issued by the European Medicines Agency.

The safety warning which should have been included in the PILs for Lamictal is located under the section titled "Before taking your medicine" or "Take special care with Lamictal" and states: "A small number of people being treated with anti-epileptics such as Lamictal have had thoughts of harming or killing themselves. If at any time you have these thoughts, immediately contact your doctor."

Lamictal contains the active ingredient Lamotrigine. Please note, other companies may distribute this medicine, but this recall only applies to select batches of Lamictal from P.I.E. Pharma Limited.

For more information and a complete list of recalled batch numbers, please visit: more information here

Source: MHRA
Publication Date: 2010-04-01
Last Updated: 2010-11-08

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