Amneal Pharmaceuticals recalls Fosphenytoin Sodium Injection, USP 500 mg PE*/10 mL, Made in India. Distributed by: Amneal Biosciences, Bridgewater, NJ
Recalled April 4, 2018 · FDA recall D-0610-2018 · Amneal Pharmaceuticals
Hazard
Presence of particulate matter · FDA Class II
Units
12,584 vials
Sold at
U.S.A Nationwide
Description
Presence of particulate matter
Product
Fosphenytoin Sodium Injection, USP 500 mg PE*/10 mL, Made in India. Distributed by: Amneal Biosciences, Bridgewater, NJ 08807, NDC 70121-1390-1
Manufacturer(s)
Amneal Pharmaceuticals
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →