Banzel (rufinamide) tablets 200 mg 120 tablets Rx only NDC 62856-582-52 Manufactured by Eisai Co., Ltd. Marketed by Eisai Inc. Woodcliff Lake, NJ 07677

Recall Number: D-0472-2021

Firm: Cardinal Health Inc.

Classification: Class II

Status: Terminated

Report Date: 20210602

Initiation Date: 20210315

Termination Date: 20240617

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Banzel (rufinamide) tablets 200 mg 120 tablets Rx only NDC 62856-582-52 Manufactured by Eisai Co., Ltd. Marketed by Eisai Inc. Woodcliff Lake, NJ 07677