Fosphenytoin Sodium Injection, USP 500 mg PE*/10 mL, Made in India. Distributed by: Amneal Biosciences, Bridgewater, NJ 08807, NDC 70121-1390-1

Recall Number: D-0610-2018

Firm: Amneal Pharmaceuticals

Classification: Class II

Status: Terminated

Report Date: 20180404

Initiation Date: 20171215

Termination Date: 20200803

Reason for Recall

Presence of particulate matter

Product Description

Fosphenytoin Sodium Injection, USP 500 mg PE*/10 mL, Made in India. Distributed by: Amneal Biosciences, Bridgewater, NJ 08807, NDC 70121-1390-1