RUFINAMIDE Recall D-1088-2023
Description: 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
RUFINAMIDE Recall D-1088-2023 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1088-2023 |
| Event ID | 92756 |
| Brand | RUFINAMIDE |
| Generic Name | RUFINAMIDE |
| Manufacturer | RUFINAMIDE |
| Original Package? | 1 |
| Active Substance | RUFINAMIDE |
| Drug Route | ORAL |
| Distribution | USA nationwide |
| Quantity | 48 bottles |
| Recall Reason | cGMP deviations: Batch was released prior to approval. |
| Drug Classification | Class II |
| Drug Code Info | 20230830 |
| Product NDC | 59651-616 59651-617 |
| Drug UPC | 0359651616086 |
| Recall Initiation Date | 20230721 |
| Report Date | 20230830 |
| Classification Date | 20230818 |
| Address | 279 Princeton Hightstown Rd East Windsor, NJ 08520-1401 United States |
| Recalling Firm | Aurobindo Pharma USA Inc. |
| Initial Notification | Letter |
| Unique Ingredient Identifier | WFW942PR79 |
| Drug Application Number | ANDA217230 |
| Structured Product Labeling (SPL ID) | d9ffc833-d902-41cb-8e8e-6bbba8e65b9e |
| Structured Product Labeling (SPL Set ID) | d9ffc833-d902-41cb-8e8e-6bbba8e65b9e |
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