FDA recall D-0282-2019

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

Reason for recall

Failed Stability Specification: out of specification for iron content.

Distribution

Product was distributed throughout the United States.

Key facts

Status

Terminated

Initiation date

2018-11-08

Report date

2018-12-05

Termination date

2020-04-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

Madison, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0282-2019