Quick answers
- What is Leucine, phenylalanine, lysine hydrochloride, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, tyrosine, serine used for?
- The FDA-approved label (Travasol, Baxter Healthcare Corporation, October 7, 2020) says: “TRAVASOL is indicated as a source of amino acids for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. TRAVASOL may be used to treat negative nitrogen balance in patients. TRAVASOL is indicated as a source of amino acids for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Leucine, phenylalanine, lysine hydrochloride, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, tyrosine, serine have a boxed warning?
- No. None of the 1 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Leucine, phenylalanine, lysine hydrochloride, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, tyrosine, serine?
- The FDA drug shortage list shows “Current shortage” for a product of this medicine (updated October 16, 2026). Ask your pharmacist about alternatives.
- Has Leucine, phenylalanine, lysine hydrochloride, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, tyrosine, serine been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started November 12, 2013 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Leucine, phenylalanine, lysine hydrochloride, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, tyrosine, serine?
- 1 company lists prescription products of Leucine, phenylalanine, lysine hydrochloride, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, tyrosine, serine in the FDA NDC Directory, including Baxter Healthcare Corporation.
What Leucine, phenylalanine, lysine hydrochloride, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, tyrosine, serine is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
TRAVASOL is indicated as a source of amino acids for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. TRAVASOL may be used to treat negative nitrogen balance in patients. TRAVASOL is indicated as a source of amino acids for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. …
— FDA label: Travasol, Baxter Healthcare Corporation, effective October 7, 2020. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
Forms and how it is given
| Dosage forms | Injection |
|---|---|
| Route | Intravenous |
| Prescription products | 1 in the FDA NDC Directory |
| Brand names | Travasol |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Baxter Healthcare Corporation1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA018931 TRAVASOL 10% IN PLASTIC CONTAINER, TRAVASOL 5.5% IN PLASTIC CONTAINER, TRAVASOL 8.5% IN PLASTIC CONTAINER | Baxter Hlthcare | August 23, 1984 | 37, latest September 23, 2020 2020: Labeling · 2017: Labeling · 2016: Manufacturing (CMC) |
Shortage status
Current shortage · updated October 16, 2026 · first posted December 8, 2020
| Product | Travasol, Injection, 2.07 g/100 mL; 1.15 g/100 mL; 1.03 g/100 mL; 480 mg/100 mL; 600 mg/100 mL; 730 mg/100 mL; 580 mg/100 mL; 400 mg/100 mL; 560 mg/100 mL; 680 |
|---|---|
| Availability | Available |
| Company | Baxter Healthcare |
Ask your pharmacist whether your product is affected and what the options are.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
November 12, 2013 · Class II · Terminated · D-368-2014
Lack of Assurance of Sterility; Drug product leaking from container therefore sterility cannot be assured
10%, Travasol (Amino Acid) Injection, 2000 ml, Pharmacy Bulk Package Not for Direct Infusion, Baxter Healthcare Corporation, Clintec Nutrition Division, Deerfield IL 60015 USA. NDC: 0338-0644-06. — Baxter Healthcare Corp.
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
| RxCUI (RxNorm) | 801644, 801648 |
|---|---|
| SPL set ID of the quoted label | 8543b5be-0f43-4891-9e56-d7c39fe839b5 |
| FDA labels (SPL) | 1 |
| FDA applications | NDA018931 |
| Active ingredients (FDA) | ALANINE / ARGININE / GLYCINE / HISTIDINE / ISOLEUCINE / LEUCINE / LYSINE / METHIONINE / PHENYLALANINE / PROLINE / SERINE / THREONINE / TRYPTOPHAN / TYROSINE / VALINE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Travasol, Baxter Healthcare Corporation, effective October 7, 2020; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →