FDAFDA · Food and drugs·Recall number D-1087-2023
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
Published August 30, 2023 · Recall initiated: July 21, 2023
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
cGMP deviations: Batch was released prior to approval.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- RUFINAMIDE
- Manufacturer
- Aurobindo Pharma USA Inc.
- Distributor
- USA nationwide
- UPC
- 0359651616086
- Lot
- Lot #: RB2023001A, Exp 02/2025
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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