Multi event Drug Recall Enforcement Report Class II voluntary initiated by Fresenius Kabi USA, LLC, originally initiated on 05-02-2014 for the product Fosphenytoin Sodium Injection, USP, 500 mg PE/10 mL (50 mg PE/mL), (PE= phenytoin sodium equivalents) 10 mL Single Use Vial, Rx only, Manufactured for APP Fresenius Kabi USA, LLC Lake Zurich, IL 60047, NDC 63323-403-10 The product was recalled due to presence of particular matter: potential glass delamination and consistent with glass particulates observed in sample vials.. 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-1429-2014 | 05-02-2014 | 07-16-2014 | Class II | 728,880 vials | Fosphenytoin Sodium Injection, USP, 500 mg PE/10 mL (50 mg PE/mL), (PE= phenytoin sodium equivalents) 10 mL Single Use Vial, Rx only, Manufactured for APP Fresenius Kabi USA, LLC Lake Zurich, IL 60047, NDC 63323-403-10 | Presence of Particular Matter: Potential glass delamination and consistent with glass particulates observed in sample vials. | Terminated |
| D-1428-2014 | 05-02-2014 | 07-16-2014 | Class II | 2,070,500 vials | Fosphenytoin Sodium Injection, USP, 100 mg PE/2 mL (50 mg PE/mL) (PE= phenytoin sodium equivalents) 2 mL Single Use Vial, Rx only, Manufactured for APP Fresenius Kabi USA, LLC Lake Zurich, IL 60047, NDC 63323-403-02 | Presence of Particular Matter: Potential glass delamination and consistent with glass particulates observed in sample vials. | Terminated |
Recalled Products
