Impax Labs issued a voluntary recall of a single lot of Lamotrigine Orally Disintegrating Tablets (ODT) due to an error in packaging where the childproof shell-packs labeled 200mg may contain 100mg blister cards.
Lamotrigine ODT is a phenyltriazine drug indicated as adjunct in partial seizures, Lennox-Gastaut syndrome, or primary generalized tonic-clonic seizures in adults and children (≥2 years); for conversion to monotherapy in adults (≥16 years) with partial seizures who are on carbamazepine, phenytoin, phenobarbital, primidone, or valproate as a single antiepileptic drug (AED).
It is also indicated as maintenance treatment of bipolar I disorder to delay the time to occurrence of mood episodes (depression, mania, hypomania, mixed episodes) in patients treated for acute mood episodes with standard therapy.
Lamotrigine is known to act upon the voltage-sensitive sodium channels to establish therapeutic effect.
The affected product was supplied as 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 3 shell-packs containing 1 blister card each. The recalled product was distributed between June 2016 and August 2016. Those in possession of the affected product should immediately stop distribution and promptly return to Impax or Stericycle.
For more information call (866) 300-2207 or visit ImpaxLabs.com.