FDA recall D-0545-2018

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.

Reason for recall

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

Distribution

Product was distributed nationwide in the USA.

Key facts

Status

Terminated

Initiation date

2017-12-13

Report date

2018-03-07

Termination date

2020-04-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Madison, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0545-2018