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

Recall Number: D-1428-2014

Firm: Fresenius Kabi USA, LLC

Classification: Class II

Status: Terminated

Report Date: 20140716

Initiation Date: 20140502

Termination Date: 20160524

Presence of Particular Matter: Potential glass delamination and consistent with glass particulates observed in sample 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