Fosphenytoin Sodium Injection, USP, 100 mg PE/2 mL (50 mg PE/mL) (PE= phenytoin Supply Disruption — Fresenius Kabi USA, LLC (Moder
Fosphenytoin Sodium Injection, USP, 100 mg PE/2 mL (50 mg PE/mL) (PE= phenytoin Supply Disruption — Fresenius Kabi USA, LLC (Moder is one of 9,000 drug supply records in the DrugSupply dataset. Key details — Drug name: Fosphenytoin Sodium Injection, USP, 100 mg PE/2 mL (50 mg PE/mL) (PE= phenytoin; Manufacturer: Fresen
| Drug name | Fosphenytoin Sodium Injection, USP, 100 mg PE/2 mL (50 mg PE/mL) (PE= phenytoin |
|---|---|
| Manufacturer | Fresenius Kabi USA, LLC |
| Recall/Disruption reason | Presence of Particular Matter: Potential glass delamination and consistent with glass particulates observed in sample vi |
| Risk classification | Moderate Risk — Temporary Health Consequence |
| Status | Terminated |
| Record type | Enforcement/Recall |
| Recall number | D-1428-2014 |
| Initiation date | 20140502 |
| Quantity affected | 2,070,500 vials |
| Dosage form | Drugs |
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