American Regent, Inc.: Tralement (trace elements injection 4*, USP), packaged in a) 1mL Single Dose vials (NDC 0517-9305-01) and b) 5x1mL S…
| Source | FDA · Drugs (US) |
|---|---|
| Date | 2026-08-26 |
| 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 |
| Official notice | — |
| Record ID | fda-drug:D-0801-2026 |