June 03, 2020
Jubilant Cadista Pharmaceuticals Inc. recalled more than 1 million lamotrigine tablets repackaged by AvKare Inc. According to the June 3, 2020, US Food and Drug Administration (FDA) Enforcement Report, a foreign substance that appeared to be silica granules was discovered amid the tablets.
The recall affects lamotrigine tablets, 150 mg, from a 20,000-count bulk container (NDC 59746-247-97) manufactured by Jubilant Cadista Pharmaceuticals for repackaging by AvKare Inc. The recalled tablets are from lots 19P0437 and 19P0438 (Exp. 9/30/21) and were distributed in Tennessee.
Jubilant Cadista Pharmaceuticals voluntarily initiated the recall May 26, 2020. On May 29, 2020, the FDA designated the recalls Class III. Under the recall classification, use of the affected tablets is not likely to cause harm.
Lamotrigine is a prescription anticonvulsant used to treat seizures as well as bipolar disorder.