FDARecalled Aug 30, 2023 · #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 59651-6...
Hazard
Class II — temporary health risk
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cGMP deviations: Batch was released prior to approval. Classification: Class II Distribution: USA nationwide
Product details
- 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
- Type
- Drugs
- Manufacturer
- Aurobindo Pharma USA Inc.
- Model numbers
- RB2023001A
- UPCs
- —