Drug 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
D-0472-2021
Product summary
- Event
- Event 87512
- Status
- Terminated
- Classification
- Class II
- Quantity
- 30 bottles
- Official record key
drug-enforcement:D-0472-2021
Official wording
Reason: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Code information: 80643
Distribution pattern: FL, GA, SC
Derived failure modes
-
Manufacturing or process control
CGMP Deviations