Fresenius Kabi USA, LLC recalls KABIVEN [(3.9%) Lipid Injectable Emulsion with (3.1%) Amino Acids and Electrolytes and (9.8%) Dextrose; Sulfite-free],…

Recall date

April 28, 2015

Source

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

Recall number

D-1114-2015

FDA classification

Class II

Brand / firm

Fresenius Kabi USA, LLC

Sold / distributed

US; Nationwide, including Puerto Rico

Why it was recalled

Labeling: Label Error on Declared Strength: Labeled 3.1% Amino Acids but contains 3.3% Amino Acids

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

KABIVEN [(3.9%) Lipid Injectable Emulsion with (3.1%) Amino Acids and Electrolytes and (9.8%) Dextrose; Sulfite-free], Rx Only. Manufactured by: FRESENIUS KABI Uppsala, Sweden. Packaged in 1) 1,540 mL Bags, NDC: 63323-712-15, and 2) 2,053 mL Bags, NDC: 63323-712-20.