Quick answers
- What is Trace elements injection 4 used for?
- The FDA-approved label (Tralement, American Regent, Inc., July 1, 2024) says: “Tralement ® is indicated in adult and pediatric patients weighing at least 10 kg as a source of zinc, copper, manganese, and selenium for 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 Trace elements injection 4 have a boxed warning?
- No. None of the 2 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Trace elements injection 4?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Trace elements injection 4 been recalled?
- FDA enforcement reports list 2 recalls of products of this medicine; the newest started July 24, 2026 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Trace elements injection 4?
- 1 company lists prescription products of Trace elements injection 4 in the FDA NDC Directory, including American Regent, Inc..
What Trace elements injection 4 is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Tralement ® is indicated in adult and pediatric patients weighing at least 10 kg as a source of zinc, copper, manganese, and selenium for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. …
— FDA label: Tralement, American Regent, Inc., effective July 1, 2024. Read the full label on DailyMed →
The FDA has 2 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
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.
0 of 2 FDA labels for this medicine have a 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.
- American Regent, Inc.2 products
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA209376 MULTRYS, TRALEMENT | Am Regent | July 2, 2020 | 2, latest July 10, 2024 2024: Labeling · 2021: Manufacturing (CMC) |
Shortage status
The FDA drug shortage list does not show these products.
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.
-
July 24, 2026 · Class II · Ongoing · D-0799-2026
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
Multrys (Trace Elements Injection 4, USP), For intravenous infusion, packaged in a) 1 mL Single-Dose Vial (NDC 0517-9302-01), and b) 25x1 mL Single-Dose Vials (NDC 0517-9302-25) Rx Only, AMERICAN REGENT, INC., SHIRLEY, N — American Regent, Inc.
-
July 24, 2026 · Class II · Ongoing · D-0801-2026
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
Tralement (trace elements injection 4*, USP), packaged in a) 1mL Single Dose vials (NDC 0517-9305-01) and b) 5x1mL Single Dose vials (NDC 0517-9305-25), Rx only, AMERICAN REGENT, INC., SHIRLEY, NY 11967. — American Regent, Inc.
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) | 2568573, 2568579, 2693627, 2693633 |
|---|---|
| SPL set ID of the quoted label | a49ffb90-f307-433e-a86e-aaea6d6a9982 |
| FDA labels (SPL) | 2 |
| FDA applications | NDA209376 |
| Active ingredients (FDA) | CUPRIC SULFATE / MANGANESE SULFATE / SELENIOUS ACID / ZINC SULFATE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Tralement, American Regent, Inc., effective July 1, 2024; 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 →