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…

Recall date

November 8, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0282-2019

FDA classification

Class II

Brand / firm

ALLERGAN

Sold / distributed

Product was distributed throughout the United States.

Why it was recalled

Failed Stability Specification: out of specification for iron content.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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