Why it was recalled
cGMP deviations: Batch was released prior to approval.
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
Lot numbers, UPCs & expiration codes
Lot #: RB2023001A, Exp 02/2025
Where it was sold
USA nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1087-2023
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 21, 2023
- FDA report date
- Aug 30, 2023
- Quantity
- 48 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Aurobindo Pharma USA Inc.
Original FDA data
Every field from FDA enforcement report D-1087-2023, exactly as published.
Show all FDA fields
- City
- East Windsor
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 92756
- Address
- 279 Princeton Hightstown Rd
- Code information
- Lot #: RB2023001A, Exp 02/2025
- Postal code
- 08520-1401
- Report date
- Aug 30, 2023
- Product type
- Drugs
- Recall number
- D-1087-2023
- Classification
- Class II
- Recalling firm
- Aurobindo Pharma USA Inc.
- Product quantity
- 48 bottles
- Termination date
- Feb 26, 2024
- Reason for recall
- cGMP deviations: Batch was released prior to approval.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- USA nationwide
- Recall initiation date
- Jul 21, 2023
- Initial firm notification
- Letter
- Center classification date
- Aug 18, 2023