Anticonvulsant Recalled

Cross contamination with other products has prompted Lundbeck to recall 10,543 cartons of Sabril (vigabatrin), according to the September 6, 2023, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects Sabril (vigabatrin) for oral solution, 500 mg, in 50-packet packages (NDC 67386-211-65), from lots 3207333A and 3207334A (Exp 3/27); and 3214707A, 3214709A, and 3214710A (Exp 2/28). The drug was manufactured by Patheon, Cincinnati, Ohio, and distributed throughout the United States.

Lundbeck voluntarily initiated the recall August 17, 2023. On August 29, 2023, the FDA designated the recall Class III, suggesting use of the recalled drug is not likely to cause harm.

Sabril is a prescription anticonvulsant used in the treatment of patients with refractory complex partial seizures and infantile spasms.