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

Recall Number: D-1429-2014

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, 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