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.
Recall initiated: 20181108
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated