FDA Issues Safety Alert on Improperly Labeled Lamotrigine

The U.S. Food and Drug Administration issued a drug safety alert on August 29, 2016, for Lamotrigine Orally Disintegrating Tablet (ODT) 200 mg produced by Impax Laboratories.

On August 19, Impax issued a voluntary recall for one lot of lamotrigine ODT 200mg because the packaging is labeled incorrectly. The affected lot, #502240, was distributed between June 13, 2016, and August 10, 2016.

Each blister card within the unit-of-use blister pack is properly labeled as 100 mg ODT; however, the plastic shell pack containing the 100 mg blister cards is incorrectly labeled as 200 mg ODT. The FDA warns, “it is possible that consumers could take less than their intended lamotrigine dose. A reduction in dose may lead to reduced therapeutic effects of lamotrigine and reemergence of epilepsy or bipolar disorder symptoms.”

People taking this medication are encouraged to inspect it carefully, and pharmacists are asked to check inventories for the affected lot.

Find more information on the FDA alert here.

Find the Impax Laboratories Press Release here.