Amneal Pharmaceuticals LLC recalls Fosphenytoin Sodium Injection, USP, 500 mg PE/10 mL (50 mg PE/mL. 10 mL Single Dose Vial, Rx Only. Distributed by: Am
Recalled November 22, 2017 · FDA recall D-0076-2018 · Amneal Pharmaceuticals
Hazard
Presence of Particulate Matter · FDA Class II
Units
14,000 vials
Sold at
MS, NC, OH, TX, UT
Description
Presence of Particulate Matter
Product
Fosphenytoin Sodium Injection, USP, 500 mg PE/10 mL (50 mg PE/mL. 10 mL Single Dose Vial, Rx Only. Distributed by: Amneal Biosciences, Bridgewater, NJ 08807. NDC: 70121-1390-7
Manufacturer(s)
Amneal Pharmaceuticals LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →