ALLERGAN recalls INFeD (Iron Dextran Injection USP) 100 mg elemental iron/2 ml (50 mg/mL), Rx Only, packaged in a) single dose vials, (N…

Recall date

December 13, 2017

Source

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

Recall number

D-0545-2018

FDA classification

Class II

Brand / firm

ALLERGAN

Sold / distributed

Product was distributed nationwide in the USA.

Why it was recalled

Failed Stability Specifications: Product stability testing results did not meet specifications 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 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.