ALLERGAN recalls INFeD (Iron Dextran Injection USP) 100 mg elemental iron/2 ml (50 mg/mL), Rx Only, packaged in a) single dose vials, (ND
Recalled March 7, 2018 · FDA recall D-0545-2018 · ALLERGAN
Hazard
Failed Stability Specifications: Product stability testing results did not meet specifications for iron content. · FDA Class II
Units
163,694 cartons
Sold at
Product was distributed nationwide in the USA.
Description
Failed Stability Specifications: Product stability testing results did not meet specifications for iron content.
Product
INFeD (Iron Dextran Injection USP) 100 mg elemental iron/2 ml (50 mg/mL), Rx Only, packaged in a) single dose vials, (NDC 52544-931-07), b) carton of 10 x 2 ml Single Dose Vials (NDC 52544-931-02) Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054, Manufactured by: Patheon Italia S.p.A. Ferentino, Italy 03013.
Manufacturer(s)
ALLERGAN
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →