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Class III Recall of Anemia Drug


December 24, 2016

More than 5000 shelf-packs of Sodium Ferric Gluconate Complex in Sucrose Injection have been recalled by the West-Ward Pharmaceuticals Corp, according to the US Food and Drug Administration’s Drug Enforcement report for the week of December 14, 2016.

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The injection is indicated for the treatment of iron deficiency anemia in adult patients and pediatric patients under the age of 6 years with chronic kidney disease receiving hemodialysis and supplemental epoetin therapy.

According to the FDA’s Report, the product was recalled because it “has an out of specification in iron assay analysis found during 18 month stability testing.” The recall was initiated voluntarily on November 17, 2016, and is currently ongoing across all of the United States.

This is a class III recall, indicating that use of, or exposure to, the product is not likely to cause severe adverse health consequences or death.—Sean McGuire

Reference

Enforcement Report. US Food and Drug Administration Website. http://www.accessdata.fda.gov/scripts/ires/index.cfm. Published December 14, 2016. Accessed December 20, 2016. 

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