Quick answers
- What is Tralement?
- Tralement is a brand name of Trace elements injection 4, a prescription medicine. The FDA NDC Directory lists 1 Tralement product in 1 strength and form.
- Who makes Tralement?
- Am Regent holds the FDA application for Tralement (NDA209376, approved July 2, 2020).
- Is there a generic or store brand of Tralement?
- Other products of Trace elements injection 4 are listed with the FDA, but none in exactly the same strength and form as a Tralement product.
- Has Tralement been recalled?
- FDA enforcement reports list 1 recall of Tralement products; the newest started July 24, 2026. A recall usually concerns specific lots, not every product.
What Tralement is
Each Tralement 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.
Trace elements injection 4 · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| cupric sulfate 0.3 mg/mL · manganese sulfate 55 ug/mL · selenious acid 60 ug/mL · zinc sulfate 3 mg/mL injection, solution (intravenous) | Tralement | None listed | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Trace elements injection 4 →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| NDA209376 | Am Regent | July 2, 2020 | 1 |
Companies that list Tralement
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Tralement products.
- American Regent, Inc.1 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.
-
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.
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.