Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Baxter SA | Lessines, Belgium | Makes it, tests it, packages it, labels it and sterilizes it | Problems found, fixed voluntarilyNov 17, 2023 · 2 inspections |
Recalls
- Jan 21, 2016 · Class I · Baxter Healthcare Corp.
Presence of Particulate Matter: identified as dried skin.
Lots: Lot #: P333930, Exp 05/31/2017 - Mar 23, 2015 · Class II · Baxter Healthcare Corp
Lack of Assurance of Sterility; increased complaints received for leaks
Lots: Product code: 2B7722; Lot#: P306365, exp date: 8/31/2015 - Nov 25, 2014 · Class II · Baxter Healthcare Corp.
Lack of Assurance of Sterility; leaks were observed from the bag seam and port seal
Lots: Product Code 2B7717 Lot # P311357, exp 12/31/2015 - Nov 18, 2013 · Class I · Baxter Healthcare Corp.
Presence of Particulate Matter: Particulate matter includes wood, sodium citrate and dextrose.
Lots: Lot#: P287045, Exp 6/2014 - Nov 18, 2013 · Class I · Baxter Healthcare Corp.
Presence of Particulate Matter: Particulate matter includes wood, sodium citrate and dextrose.
Lots: Lot#: P275883, Exp 10/2013
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threo: every company that makes it
- Form
- injection, intravenous
- Strength
- 21 ingredients
- Approval
- NDA NDA020678
- On the market since
- Jul 15, 2024
- Package NDCs
0338-7036-010338-7036-04- Official label
- DailyMed (National Library of Medicine), updated Apr 13, 2021
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