Drug product
Rufinamide Tablets, USP 400 mg, packaged in 120-count bottle, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India, NDC 59651-617-08
D-1088-2023
Product summary
- Event
- Event 92756
- Status
- Terminated
- Classification
- Class II
- Quantity
- 48 bottles
- Official record key
drug-enforcement:D-1088-2023
Official wording
Reason: cGMP deviations: Batch was released prior to approval.
Code information: Lot #: RB4023002A, Exp 02/2025
Distribution pattern: USA nationwide
Derived failure modes
-
Manufacturing or process control
cGMP deviations