Rufinamide Tablets recall: CGMP Deviations
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
Why was Rufinamide Tablets recalled?
cGMP deviations: Batch was released prior to approval.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: RB4023002A, Exp 02/2025
- 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
- Recalling firm
- Aurobindo Pharma USA Inc.
- Quantity
- 48 bottles
- Distribution
- USA nationwide
- Recall date
- August 30, 2023
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)