Impax Laboratories Recalls Lamotrigine Orally Disintegrating Tablets

Impax Laboratories announced on August 26, 2016 that it was recalling one lot of Lamotrigine Orally Disintegrating Tablet (ODT) 200 mg because blister packs may contain 100 mg product instead of 200 mg product. The recalled lot, 502240, was distributed nationwide between June 13, 2016 and August 10, 2016.

Each unit-of-use blister pack (10 count blister card contained in a single plastic shell-pack) is labeled as 100 mg ODT; however, the company reports, the plastic shell pack containing the 100 mg cards is labeled as 200 mg ODT. Shell-packs from the affected lot may contain 100 mg ODT instead of 200 mg ODT. Consumers may possibly take less than their intended lamotrigine dose.

According to the company, lamotrigine is indicated for the treatment of epilepsy or bipolar disorders. A reduction in dose may lead to reduced therapeutic effects of lamotrigine and reemergence of epilepsy or bipolar disorder symptoms.

The company is asking pharmacists and wholesalers to check their inventory for the affected lot, segregate any material from the lot, and return the product.

Source: FDA