FDA-Drug2015-06-10Class II
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.
Fresenius Kabi USA, LLC
Hazard
Labeling: Label Error on Declared Strength: Labeled 3.1% Amino Acids but contains 3.3% Amino Acids
Sold states
US; Nationwide, including Puerto Rico
Affected count
5,488 Bags
Manufactured in
3 Corporate Dr, N/A, Lake Zurich, IL, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1114-2015Don't want to check this manually?
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