FDA-Drug2018-12-05Class II
INFed (Iron Dextran Injection USP) 100 mg elemental iron/2 mL (50 mg/mL), Rx only, packaged in 2 mL Sterile Single Dose Vial, Mfd by Patheon Italia S.p.A. Ferentino, Italy NDC 52544-931-07
ALLERGAN
Hazard
Failed Stability Specification: out of specification for iron content.
Sold states
Product was distributed throughout the United States.
Affected count
111,132 cartons/10 vials per carton
Manufactured in
1 Giralda Farms, N/A, Madison, NJ, United States
Products
INFed (Iron Dextran Injection USP) 100 mg elemental iron/2 mL (50 mg/mL), Rx only, packaged in 2 mL Sterile Single Dose Vial, Mfd by Patheon Italia S.p.A. Ferentino, Italy NDC 52544-931-07
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0282-2019Don'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