ALLERGAN recalls INFed (Iron Dextran Injection USP) 100 mg elemental iron/2 mL (50 mg/mL), Rx only, packaged in 2 mL Sterile Single Dose
Recalled December 5, 2018 · FDA recall D-0282-2019 · ALLERGAN
Hazard
Failed Stability Specification: out of specification for iron content. · FDA Class II
Units
111,132 cartons/10 vials per carton
Sold at
Product was distributed throughout the United States.
Description
Failed Stability Specification: out of specification for iron content.
Product
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
Manufacturer(s)
ALLERGAN
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →