Rufinamide Tablets, USP 400 mg, packaged in 120-count bottle, Rx only, Distribut Supply Disruption — Aurobindo Pharma USA Inc. (Mo
Rufinamide Tablets, USP 400 mg, packaged in 120-count bottle, Rx only, Distribut Supply Disruption — Aurobindo Pharma USA Inc. (Mo is one of 9,000 drug supply records in the DrugSupply dataset. Key details — Drug name: Rufinamide Tablets, USP 400 mg, packaged in 120-count bottle, Rx only, Distribut; Manufacturer: Aurob
| Drug name | Rufinamide Tablets, USP 400 mg, packaged in 120-count bottle, Rx only, Distribut |
|---|---|
| Manufacturer | Aurobindo Pharma USA Inc. |
| Recall/Disruption reason | cGMP deviations: Batch was released prior to approval. |
| Risk classification | Moderate Risk — Temporary Health Consequence |
| Status | Terminated |
| Record type | Enforcement/Recall |
| Recall number | D-1088-2023 |
| Initiation date | 20230721 |
| Quantity affected | 48 bottles |
| Dosage form | Drugs |
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