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 SA | Lessines, Belgium | Makes it, tests it, packages it, labels it and sterilizes it | Problems found, fixed voluntarilyNov 17, 2023 · 2 inspections |
| Baxter Healthcare Corporation | Round Lake, IL, United States | Tests it | Serious problems, FDA actionApr 2, 2026 · 15 inspections, 2 with FDA action |
Recalls
- Nov 12, 2013 · Class II · Baxter Healthcare Corp.
Lack of Assurance of Sterility; Drug product leaking from container therefore sterility cannot be assured
Lots: Lot: P302646, Exp 5/31/15
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 Hydrochloride, Methionine, Isoleucine, Valine, Hi: every company that makes it
- Form
- injection, intravenous
- Strength
- 15 ingredients
- Approval
- NDA NDA018931
- On the market since
- Aug 23, 1984
- Package NDCs
0338-0644-030338-0644-040338-0644-06- Official label
- DailyMed (National Library of Medicine), updated Oct 7, 2020
Got it by mail or from a pharmacy you don't know? Look the pharmacy up on Who Filled My Rx?