Status
Terminated
Drug Enforcement D-1088-2023
cGMP deviations: Batch was released prior to approval.
Classification
Class II
Report Date
August 30, 2023
Termination Date
February 26, 2024
Product Information
- Product description
- 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
- Product quantity
- 48 bottles
- Reason for recall
- cGMP deviations: Batch was released prior to approval.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- USA nationwide
Location & Firm
- Recalling firm
- Aurobindo Pharma USA Inc.
- Address
-
279 Princeton Hightstown Rd, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-1088-2023
- Event ID
- 92756
- Recall initiation date
- July 21, 2023
- Center classification date
- August 18, 2023
- Code info
- Lot #: RB4023002A, Exp 02/2025
- More code info
- —