FDA-Drug2017-11-22Class II
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
Amneal Pharmaceuticals LLC
Hazard
Presence of Particulate Matter
Sold states
MS, NC, OH, TX, UT
Affected count
14,000 vials
Manufactured in
118 Beaver Trl, N/A, Glasgow, KY, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0076-2018Don'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