Impax Laboratories issues voluntary, nationwide recall for one lot of Lamotrigine orally disintegrating tablet 200 mg

Potential for 100 mg blister cards being packaged in 200 mg containers.

Unit-of-use blister packs (a 10-count blister card contained in a single plastic shell-pack) may contain 100 mg product instead of 200 mg product. 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 labeled as 200 mg ODT. Shell-packs from the affected lot may contain 100 mg ODT instead of 200 mg ODT, and as a result, it is possible that consumers could take less than their intended lamotrigine dose.

Lamotrigine is indicated for the treatment of epilepsy or bipolar disorders. It is important for consumers to take the dose of lamotrigine prescribed by their physicians. A reduction in dose may lead to reduced therapeutic effects of lamotrigine and reemergence of epilepsy or bipolar disorder symptoms.

The affected lot was distributed between 13 June 2016 and 10 August 2016 to wholesale distributors and retail pharmacies nationwide. The lot number can be found on the side of the manufacturer's carton as well as on the blister cards within the unit-of-use blister packs. Lamotrigine ODT 200 mg tablets are off-white to white circular tablets, approximately 14 mm in diameter, debossed with "WPI" on one side and "3724" on the other, supplied in blisters of 10 (NDC 0115-1529-15) and in cartons of 30 (NDC 0115-1529-08).