Drug recall D-0472-2021
Product
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
Reason for recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Lots and codes
80643
Recall details
- Recalling firm
- Cardinal Health Inc., Dublin, OH
- Quantity
- 30 bottles
- Distribution
- FL, GA, SC
- Type
- Voluntary: Firm initiated
- Recall initiated
- March 15, 2021
- Terminated
- June 17, 2024
Related products
- Banzel – drug information
- NDC 62856-582 Banzel · Rufinamide 200 mg/1 · Eisai Inc.
- NDC 62856-584 Banzel · Rufinamide 40 mg/mL · Eisai Inc.
- NDC 62856-583 Banzel · Rufinamide 400 mg/1 · Eisai Inc.