Official recall notice

FDA DrugClass IINotable

Tralement Recall (Aug 2026) – American Regent

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.

Recall date
2026-08-26
Category
Drug
FDA class
Class II

Why it was recalled

Hazard

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

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Product description

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

Affected products

Lot #: 25149, Exp. Date: 04/30/2027; 25371, Exp. Date: 09/30/2027.

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