D-0801-2026 Class II Ongoing
FDA drug recall D-0801-2026 was initiated by American Regent, Inc. on July 24, 2026 and is designated Class II. Reason for recall: Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde The recall status is ongoing. Affected quantity: 323,000 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- August 26, 2026
- Initiation Date
- July 24, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 323,000 vials
Product Description
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
Distribution Pattern
Nationwide within the U.S
Code Information
Lot #: 25149, Exp. Date: 04/30/2027; 25371, Exp. Date: 09/30/2027.