Fosphenytoin Sodium Injection, USP 500 mg PE*/10 mL, Made in India. Distributed by: Amneal Biosci...
FDA Recall #D-0610-2018 — Class II — December 15, 2017
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
Reason for Recall
Presence of particulate matter
Recalling Firm
Amneal Pharmaceuticals — Brookhaven, NY
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
12,584 vials
Distribution
U.S.A Nationwide
Code Information
Lot #: AP160022, AP160023, Exp. 05/2018; AP16038, AP160039, AP160040, Exp. 06/2018; AP160076, AP160077, AP160078, Exp. 12/2018
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated