Quick answers
- What is ProSol?
- ProSol is a brand name of Valine, lysine, histidine, isoleucine, leucine, phenylalanine, threonine, methionine, tryptophan, alanine, glycine, arginine, proline, glutamic acid, serine, aspartic acid and tyrosine, a prescription medicine. The FDA NDC Directory lists 1 ProSol product in 1 strength and form.
- Who makes ProSol?
- Baxter Hlthcare holds the FDA application for ProSol (NDA020849, approved August 26, 1998).
- Is there a generic or store brand of ProSol?
- Other products of Valine, lysine, histidine, isoleucine, leucine, phenylalanine, threonine, methionine, tryptophan, alanine, glycine, arginine, proline, glutamic acid, serine, aspartic acid and tyrosine are listed with the FDA, but none in exactly the same strength and form as a ProSol product.
- Has ProSol been recalled?
- FDA enforcement reports list 1 recall of ProSol products; the newest started August 4, 2014. A recall usually concerns specific lots, not every product.
What ProSol is
Each ProSol product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.
Valine, lysine, histidine, isoleucine, leucine, phenylalanine, threonine, methionine, tryptophan, alanine, glycine, arginine, proline, glutamic acid, serine, aspartic acid and tyrosine · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| alanine 2.76% · arginine 1.96% · aspartic acid 600 mg/100 mL · glutamic acid 1.02% · glycine 2.06% · histidine 1.18% · isoleucine 1.08% · leucine 1.08% · lysine acetate 1.35% · methionine 760 mg/100 mL · phenylalanine 1% · proline 1.34% · serine 1.02% · threonine 980 mg/100 mL · tryptophan 320 mg/100 mL · tyrosine 50 mg/100 mL · valine 1.44% injection, solution (intravenous) | ProSol | None listed | — |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Valine, lysine, histidine, isoleucine, leucine, phenylalanine, threonine, methionine, tryptophan, alanine, glycine, arginine, proline, glutamic acid, serine, aspartic acid and tyrosine →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| NDA020849 | Baxter Hlthcare | August 26, 1998 | 1 |
Companies that list ProSol
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of ProSol products.
- Baxter Healthcare Corporation1 product
Recalls
From FDA enforcement reports, matched by the product’s NDC code or label. A recall usually covers specific lots: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
August 4, 2014 · Class II · Terminated · D-1542-2014
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).
ProSol - sulfite-free (Amino Acid) Injection, 20%, 2000 mL VIAFLEX container bag, Rx only, Baxter Healthcare Corporation, Clinitec Nutrition Division, Deerfield, IL 60015 USA, Product Code 2B6186, NDC 0338-0499-06. — Baxter Healthcare Corp
Sources
- 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 labeling (SPL, 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
- NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026
Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.