Class IIDrugOngoing

American Regent, Inc.

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.

Reason for recall

Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde

Details

Recall number: D-0801-2026
Event ID: 99503
Recall initiated: Jul 24, 2026
Classified: Aug 26, 2026
Reported: Aug 26, 2026
Quantity: 323,000 vials
Distribution: Nationwide within the U.S
Initiated by: Voluntary: Firm initiated
Firm notification: Press Release
Firm location: Shirley, NY, United States
Lot / code info: Lot #: 25149, Exp. Date: 04/30/2027; 25371, Exp. Date: 09/30/2027.