NDC 0338-0499
ProSol 17 ingredients injection, solution
On the label: Baxter Healthcare Corporation.
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
- Aug 4, 2014 · Class II · Baxter Healthcare Corp
Presence of Particulate Matter: identification of particulates in a retention sample that have been identified as a mixture of the amino acid leucine and inorganic material (containing iron, silicone and chlorine).
Lots: Lot #: P306225, Exp 08/14
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Lysine Acetate, Leucine, Phenylalanine, Valine, Isoleucine, Methionine, Threonin: every company that makes it
- Form
- injection, solution, intravenous
- Strength
- 17 ingredients
- Approval
- NDA NDA020849
- On the market since
- Aug 26, 1998
- Package NDCs
0338-0499-06- Official label
- DailyMed (National Library of Medicine), updated Oct 7, 2020
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