Drug recall D-1087-2023
Product
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
Reason for recall
cGMP deviations: Batch was released prior to approval.
Lots and codes
Lot #: RB2023001A, Exp 02/2025
Recall details
- Recalling firm
- Aurobindo Pharma USA Inc., East Windsor, NJ
- Quantity
- 48 bottles
- Distribution
- USA nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- July 21, 2023
- Terminated
- February 26, 2024
Related products
- Rufinamide – drug information
- NDC 59651-617 Rufinamide · Rufinamide 400 mg/1 · Aurobindo Pharma Limited
- NDC 59651-616 Rufinamide · Rufinamide 200 mg/1 · Aurobindo Pharma Limited