Fresenius Kabi USA, LLC recalls Fosphenytoin Sodium Injection, USP, 100 mg PE/2 mL (50 mg PE/mL) (PE= phenytoin sodium equivalents) 2 mL Single Use Via
Recalled July 16, 2014 · FDA recall D-1428-2014 · Fresenius Kabi USA
Hazard
Presence of Particular Matter: Potential glass delamination and consistent with glass particulates observed in sample vials. · FDA Class II
Units
2,070,500 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, 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
Manufacturer(s)
Fresenius Kabi USA, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →