FDA Drug recall D-1114-2015
KABIVEN [(3.9%) Lipid Injectable Emulsion with (3.1%) Amino Acids and Electrolytes and (9.8%) Dextrose
- FDA Drug
- Class II
- terminated
- Published 2015-06-10
On 2015-06-10 the FDA classified a Class II recall of KABIVEN [(3.9%) Lipid Injectable Emulsion with (3.1%) Amino Acids and Electrolytes and (9.8%) Dextrose by Fresenius Kabi Usa, citing labeling: Label Error on Declared Strength: Labeled 3.1% Amino Acids but contains 3.3% Amino Acids.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1114-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-04-28 |
| Published | 2015-06-10 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Fresenius Kabi Usa |
| Distribution | US |
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.
Reason
Labeling: Label Error on Declared Strength: Labeled 3.1% Amino Acids but contains 3.3% Amino Acids
Identifiers
| ndc | 63323-712-10 |
|---|---|
| ndc | 63323-712-15 |
| ndc | 63323-712-20 |
| ndc | 63323-712-25 |
| code_info | 1) Lot # 10HH8781, Expiry: 07-2016; 2) Lot # 10HH8739, Expiry: 07-2016. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1114-2015%22
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