Impax Labs is recalling a single lot of the anti-seizure drug Lamotrigine Orally Disintegrating Tablets (ODT) because the childproof shell-packs labeled 200 mg may only contain 100 mg blister cards.
Lamotrigine ODT is a phenyltriazine drug used as an adjunct to treat partial seizures, Lennox-Gastaut syndrome, or primary generalized tonic-clonic seizures in adults and children 2 years of age and older. It is also used as a conversion to monotherapy in adults 16 years and older with partial seizures who are on carbamazepine, phenytoin, phenobarbital, primidone, or valproate as a single antiepileptic drug (AED).
Lamotrigine is also used as a maintenance treatment for patients with bipolar I disorder to delay the time to occurrence of mood episodes –such as depression, mania, hypomania, or mixed episodes – in patients treated for acute mood episodes with standard therapy. The drug works by acting on the voltage-sensitive sodium channels.
The affected lot of Lamotrigine Orally Disintegrating Tablets was supplied in 30-count boxes with Lot # 502240 and an expiration date of 11/2017. It was packaged in a final configuration of a single carton with three shell-packs containing one blister card each. The recalled product was distributed between June 2016 and August 2016. Impax Labs is asking its distributors with affected products in their possession to stop distributing them immediately and promptly return them to Impax or Stericycle.
Consumers with affected products should contact their doctors with questions. Any side effects related to medication affected by this recall should be reported to the Food and Drug Administration (FDA) MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.