Drug recall D-0798-2026
Product
Selenious Acid Injection, USP 12 mcg/2 mL (6 mcg/2mL), For intravenous use, packaged in a) 2mL Single-Dose Vial (NDC 0517-6502-01), and b)10x2mL Single-Dose Vial (NDC 0517-6502-10), 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 #: 25090, Exp. Date 2/28/2027.
Recall details
- Recalling firm
- American Regent, Inc., Shirley, NY
- Quantity
- 41,680 vials
- Distribution
- Nationwide within the U.S
- Type
- Voluntary: Firm initiated
- Recall initiated
- July 24, 2026
Related products
- Selenious Acid – drug information
- NDC 0517-6502 Selenious Acid · Selenium 6 ug/mL · American Regent, Inc.
- NDC 0517-6560 Selenious Acid · Selenium 60 ug/mL · American Regent, Inc.