Drug recall D-0801-2026
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 for recall
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
Lots and codes
Lot #: 25149, Exp. Date: 04/30/2027; 25371, Exp. Date: 09/30/2027.
Recall details
- Recalling firm
- American Regent, Inc., Shirley, NY
- Quantity
- 323,000 vials
- Distribution
- Nationwide within the U.S
- Type
- Voluntary: Firm initiated
- Recall initiated
- July 24, 2026
Related products
- Tralement – drug information
- NDC 0517-9305 Tralement · Zinc Sulfate 3 mg/mL; Cupric Sulfate .3 mg/mL; Manganese… · American Regent, Inc.