For Immediate Release
August 26, 2016
Impax Laboratories, Inc. (NASDAQ: IPXL) announced today that the Company had issued a voluntary nationwide retail level recall on August 19, 2016 for one lot of Lamotrigine Orally Disintegrating Tablet (ODT) 200 mg. The Company is issuing this press release to provide further heightened awareness of this recall and to provide instructions to consumers, pharmacists, and wholesalers in possession of the affected product. Details related to the recalled product are set forth below.
|NDC Number||Blister Pack||Lot Number|
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 June 13, 2016 and August 10, 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). (more…)