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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 05

DrugsSource: FDA (drug) · Date: 2026-08-26

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The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.

Company / brand
American Regent, Inc.
Product
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 / hazard
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
Classification
Class II
Status
Ongoing
Distribution / sold at
Nationwide within the U.S
Recall initiated
2026-07-24
Code info
Lot #: 25149, Exp. Date: 04/30/2027; 25371, Exp. Date: 09/30/2027.
Product quantity
323,000 vials
Voluntary mandated
Voluntary: Firm initiated
City
Shirley
State
NY
Country
United States
Event id
99503
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