December 07, 2018
Allergan is recalling numerous lots of INFeD (iron dextran injection USP) 100-mg elemental iron/2 mL (50 mg/mL) because samples of the drug tested out-of-specification for iron content, according to the December 5, 2018, US Food and Drug Administration (FDA) Enforcement Report.
Packaged in 2-mL sterile single-dose vials (NDC 52544-931-07), the recalled INFeD is from the following lots: 16W06A, 16W07A, and 16W08A (Exp. 2/19); 16W09A and 16W10A (Exp. 3/19); 16W11A and 16W14A (Exp. 4/19); 16W21A (Exp. 9/19); 16W23A (Exp. 11/19); 17W10A (Exp. 4/20); 17W12A (Exp. 5/20); 17W16A and 17W18A (Exp. 6/20); and 17W22A (Exp. 8/20). Vials from the lots were distributed throughout the United States.
Allergan voluntarily initiated the recall November 8, 2018. The FDA designated the recall Class II on November 23, 2018. The classification signals use of the affected drug may cause temporary or medically reversible adverse health consequences, or a remote possibility of serious harm.
INFeD is a prescription injection used to treat patients with iron-deficiency anemia who cannot be treated with oral iron supplements.
For more Pharmacy Learning Network articles, visit the homepage