Recalls / Class II
Class IID-1088-2023
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
- Brand name
- Rufinamide
- Generic name
- Rufinamide
- Active ingredient
- Rufinamide
- Route
- Oral
- NDCs
- 59651-616, 59651-617
- FDA application
- ANDA217230
- Affected lot / code info
- Lot #: RB4023002A, Exp 02/2025
Why it was recalled
cGMP deviations: Batch was released prior to approval.
Recalling firm
- Firm
- Aurobindo Pharma USA Inc.
- Manufacturer
- Aurobindo Pharma Limited
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 279 Princeton Hightstown Rd, N/A, East Windsor, New Jersey 08520-1401
Distribution
- Quantity
- 48 bottles
- Distribution pattern
- USA nationwide
Timeline
- Recall initiated
- 2023-07-21
- FDA classified
- 2023-08-18
- Posted by FDA
- 2023-08-30
- Terminated
- 2024-02-26
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1088-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.