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.
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