FDA-Drug2018-04-04Class II

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

Hazard

Presence of particulate matter

Sold states
U.S.A Nationwide
Affected count
12,584 vials
Manufactured in
50 Horseblock Rd, Brookhaven, NY, United States
Products
Fosphenytoin Sodium Injection, USP 500 mg PE*/10 mL, Made in India. Distributed by: Amneal Biosciences, Bridgewater, NJ 08807, NDC 70121-1390-1

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0610-2018

Don't want to check this manually?

We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.

Get the Sunday Brief