FDAFDA · Food and drugs·Recall number D-0801-2026
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.
Published August 26, 2026 · Recall initiated: July 24, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
What to do
Voluntary: Firm initiated · Press Release
Recall details
- Brand
- TRALEMENT
- Manufacturer
- American Regent, Inc.
- Distributor
- Nationwide within the U.S
- UPC
- 0305178201250
- Lot
- Lot #: 25149, Exp. Date: 04/30/2027; 25371, Exp. Date: 09/30/2027.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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