Anticonvulsant Recalled

Aurobindo Pharma USA Inc. is pulling 96 bottles of rufinamide tablets that were released prior to approval, according to the August 30, 2023, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects the following products, which were made in India and distributed throughout the United States by Aurobindo Pharma USA Inc., East Windsor, New Jersey:

• rufinamide tablets, 200 mg, in 120-count bottles (NDC 59651-616-08), from lot RB2023001A (Exp. 2/25); and
• rufinamide tablets, 400 mg, in 120-count bottles (NDC 59651-617-08), from lot RB4023002A (Exp. 2/25).

Aurobindo Pharma USA voluntarily initiated the recall July 21, 2023. On August 18, 2023, the FDA designated it Class II. The use of a product under a Class II recall could cause temporary or medically reversible adverse health consequences, or a remote possibility of serious harm.

Rufinamide is a prescription medication indicated for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome.