# FDA recall D-1114-2015

> **Fresenius Kabi USA, LLC** · Class II · drug recall initiated 2015-04-28.

## 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 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

## Key facts

- **Recall number:** D-1114-2015
- **Recalling firm:** Fresenius Kabi USA, LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2015-04-28
- **Report date:** 2015-06-10
- **Termination date:** 2016-05-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Lake Zurich, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1114-2015

## Citation

> AI Analytics. FDA recall D-1114-2015. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-1114-2015. Source: US FDA. Licensed CC0.

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