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
Reason for recall: Presence of Particular Matter: Potential glass delamination and consistent with glass particulates observed in sample vials.
Recall initiated: 20140502
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated