RecallDepth
Class II Terminated

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.

Company
Fresenius Kabi Usa, Llc
Recall Initiated
April 28, 2015
Posted
June 10, 2015
Recall Number
D-1114-2015
Voluntary / Mandated
Voluntary: Firm initiated
Quantity
5,488 Bags
Firm Location
Lake Zurich, IL, United States

Reason for Recall

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

Distribution

US; Nationwide, including Puerto Rico

Lot / Code Info

1) Lot # 10HH8781, Expiry: 07-2016; 2) Lot # 10HH8739, Expiry: 07-2016.

More recalls by Fresenius Kabi Usa, Llc

View all recalls by this company →

Other recent Class II Drug recalls