Fresenius Kabi USA, LLC recalls Fosphenytoin Sodium Injection, USP, 500 mg PE/10 mL (50 mg PE/mL), (PE= phenytoin sodium equivalents) 10 mL Single Use V
Recalled July 16, 2014 · FDA recall D-1429-2014 · Fresenius Kabi USA
Hazard
Presence of Particular Matter: Potential glass delamination and consistent with glass particulates observed in sample vials. · FDA Class II
Units
728,880 vials
Sold at
Nationwide and Puerto Rico
Description
Presence of Particular Matter: Potential glass delamination and consistent with glass particulates observed in sample vials.
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
Manufacturer(s)
Fresenius Kabi USA, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →