Drug 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.
D-1114-2015
Product summary
- Event
- Event 71222
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5,488 Bags
- Official record key
drug-enforcement:D-1114-2015
Official wording
Reason: Labeling: Label Error on Declared Strength: Labeled 3.1% Amino Acids but contains 3.3% Amino Acids
Code information: 1) Lot # 10HH8781, Expiry: 07-2016; 2) Lot # 10HH8739, Expiry: 07-2016.
Distribution pattern: US; Nationwide, including Puerto Rico
Derived failure modes
-
Labeling or packaging
Labeling: Label Error