Quick answers
- What is Valine, lysine, histidine, isoleucine, leucine, phenylalanine, threonine, methionine, tryptophan, alanine, glycine, arginine, proline, glutamic acid, serine, aspartic acid and tyrosine used for?
- The FDA-approved label (Plenamine, B. Braun Medical Inc., May 8, 2026) says: “Plenamine™ 15% is indicated as an amino acid (nitrogen) source in parenteral nutrition regimens. This use is appropriate when the enteral route is inadvisable, inadequate or not possible, as when: — Gastrointestinal absorption is impaired by obstruction, inflammatory disease or its complications, or antineoplastic therapy …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Valine, lysine, histidine, isoleucine, leucine, phenylalanine, threonine, methionine, tryptophan, alanine, glycine, arginine, proline, glutamic acid, serine, aspartic acid and tyrosine 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 Valine, lysine, histidine, isoleucine, leucine, phenylalanine, threonine, methionine, tryptophan, alanine, glycine, arginine, proline, glutamic acid, serine, aspartic acid and tyrosine?
- The FDA drug shortage list shows “Current shortage” for a product of this medicine (updated October 19, 2026). Ask your pharmacist about alternatives.
- Has Valine, lysine, histidine, isoleucine, leucine, phenylalanine, threonine, methionine, tryptophan, alanine, glycine, arginine, proline, glutamic acid, serine, aspartic acid and tyrosine been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started August 4, 2014 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Valine, lysine, histidine, isoleucine, leucine, phenylalanine, threonine, methionine, tryptophan, alanine, glycine, arginine, proline, glutamic acid, serine, aspartic acid and tyrosine?
- 2 companies list prescription products of Valine, lysine, histidine, isoleucine, leucine, phenylalanine, threonine, methionine, tryptophan, alanine, glycine, arginine, proline, glutamic acid, serine, aspartic acid and tyrosine in the FDA NDC Directory, including Baxter Healthcare Corporation and B. Braun Medical Inc..
What Valine, lysine, histidine, isoleucine, leucine, phenylalanine, threonine, methionine, tryptophan, alanine, glycine, arginine, proline, glutamic acid, serine, aspartic acid and tyrosine is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Plenamine™ 15% is indicated as an amino acid (nitrogen) source in parenteral nutrition regimens. This use is appropriate when the enteral route is inadvisable, inadequate or not possible, as when: — Gastrointestinal absorption is impaired by obstruction, inflammatory disease or its complications, or antineoplastic therapy …
— FDA label: Plenamine, B. Braun Medical Inc., effective May 8, 2026. 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
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 Corporation2 products
- B. Braun Medical Inc.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA020849 PROSOL 20% SULFITE FREE IN PLASTIC CONTAINER | Baxter Hlthcare | August 26, 1998 | 11, latest September 23, 2020 2020: Labeling · 2018: Labeling · 2014: Manufacturing (CMC) |
Generic approvals (2)
- ANDA020512Baxter Hlthcare · August 30, 1996
- ANDA091112B Braun · April 13, 2012
Shortage status
Current shortage · updated October 19, 2026 · first posted December 8, 2020
| Product | Plenamine, Injection, 0.15 (NDC 0264-4500-00) |
|---|---|
| Availability | Available |
| Company | B. Braun Medical Inc. |
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.
-
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
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) | 800584, 1601982 |
|---|---|
| SPL set ID of the quoted label | a3244d1a-45b0-4e4c-bd96-f0632d761a1f |
| FDA labels (SPL) | 1 |
| FDA applications | NDA020849, 2 ANDA |
| Active ingredients (FDA) | ALANINE / ARGININE / ASPARTIC ACID / GLUTAMIC ACID / GLYCINE / HISTIDINE / ISOLEUCINE / LEUCINE / LYSINE ACETATE / METHIONINE / PHENYLALANINE / PROLINE / SERINE / THREONINE / TRYPTOPHAN / TYROSINE / VALINE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Plenamine, B. Braun Medical Inc., effective May 8, 2026; 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 →