Fresenius Kabi USA, LLC recalls KABIVEN [(3.9%) Lipid Injectable Emulsion with (3.1%) Amino Acids and Electrolytes and (9.8%) Dextrose; Sulfite-free], R
Recalled June 10, 2015 · FDA recall D-1114-2015 · Fresenius Kabi USA
Hazard
Labeling: Label Error on Declared Strength: Labeled 3.1% Amino Acids but contains 3.3% Amino Acids · FDA Class II
Units
5,488 Bags
Sold at
US; Nationwide, including Puerto Rico
Description
Labeling: Label Error on Declared Strength: Labeled 3.1% Amino Acids but contains 3.3% Amino Acids
Product
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.
Manufacturer(s)
Fresenius Kabi USA, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →