Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Baxter Healthcare Corporation | Marion, NC, United States | Makes it, tests it, packages it, labels it and sterilizes it | Serious problems, FDA actionFeb 9, 2024 · 9 inspections, 3 with FDA action |
| Baxter Healthcare Corporation | Jayuya, PR, United States | Makes it, tests it, packages it, labels it and sterilizes it | Problems found, fixed voluntarilyJul 19, 2024 · 15 inspections, 5 with FDA action |
| Baxter Healthcare Corporation | Round Lake, IL, United States | Tests it | Serious problems, FDA actionApr 2, 2026 · 15 inspections, 2 with FDA action |
Recalls
- Nov 18, 2013 · Class I · Baxter Healthcare Corp.
Presence of Particulate Matter: Particulate matter includes wood, sodium citrate and dextrose.
Lots: Lot# P285122, Exp 5/2014
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
- 16 ingredients
- Approval
- NDA NDA020734
- On the market since
- Sep 29, 1997
- Package NDCs
0338-1133-03- Official label
- DailyMed (National Library of Medicine), updated Apr 13, 2021
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