Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Fresenius Kabi AB | Uppsala, Sweden | Makes it, makes the active ingredient and tests it | Problems found, fixed voluntarilyJan 24, 2025 · 8 inspections |
Recalls
- Apr 28, 2015 · Class II · Fresenius Kabi USA, LLC
Labeling: Label Error on Declared Strength: Labeled 3.1% Amino Acids but contains 3.3% Amino Acids
Lots: 1) Lot # 10HH8781, Expiry: 07-2016; 2) Lot # 10HH8739, Expiry: 07-2016.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Dextrose, Soybean Oil, Electrolytes, Lysine, Phenylalanine, Leucine, Valine, Thr: every company that makes it
- Form
- injection, emulsion, intravenous
- Strength
- 24 ingredients
- Approval
- NDA NDA200656
- On the market since
- Aug 25, 2014
- Package NDCs
63323-712-1063323-712-1563323-712-2063323-712-25- Official label
- DailyMed (National Library of Medicine), updated Sep 11, 2025
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