Rufinamide Tablet, Film Coated
FDA Recall NDC 59651-616
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Rufinamide (NDC 59651-616). A significant event, classified as Class II, was initiated on Jul 21, 2023 by Aurobindo Pharma Limited. The reported reason for this action was: "cGMP deviations: Batch was released prior to approval."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
cGMP deviations: Batch was released prior to approval.
Jul 21, 2023
Aug 30, 2023
48 bottles
Recall Profile & Regulatory Data
Event ID
92756
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Aurobindo Pharma USA Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA nationwide
Termination Date
Feb 26, 2024
Product Description
Rufinamide Tablets, USP 200 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 59651-616-08
Batch or Lot Expiration Information
Lot# : RB2023001A, Exp 02/2025
Affected Packages Involved in this Recall
59651-616-08Product
59651-617-08Product
Class II Terminated
cGMP deviations: Batch was released prior to approval.
Jul 21, 2023
Aug 30, 2023
48 bottles
Recall Profile & Regulatory Data
Event ID
92756
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Aurobindo Pharma USA Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA nationwide
Termination Date
Feb 26, 2024
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
Batch or Lot Expiration Information
Lot# : RB4023002A, Exp 02/2025
Affected Packages Involved in this Recall
59651-616-08Product
59651-617-08Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
