Multi event Drug Recall Enforcement Report Class II voluntary initiated by Aurobindo Pharma USA Inc., originally initiated on 07-21-2023 for the 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 The product was recalled due to cgmp deviations: batch was released prior to approval.. The product was distributed nationwide and the recall is currently terminated.
Recall Enforcement Reports
| Recall Number |
Recall Initiation Date |
Report Date |
Recall Classification |
Quantity |
Product Description |
Recall Reason |
Status |
| D-1087-2023 | 07-21-2023 | 08-30-2023 | Class II | 48 bottles | 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 | cGMP deviations: Batch was released prior to approval. | Terminated |
| D-1088-2023 | 07-21-2023 | 08-30-2023 | Class II | 48 bottles | 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 | cGMP deviations: Batch was released prior to approval. | Terminated |
Recalled Products
