D-0798-2026 Class II Ongoing
FDA drug recall D-0798-2026 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: 41,680 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
- 41,680 vials
Product Description
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
Distribution Pattern
Nationwide within the U.S
Code Information
Lot #: 25090, Exp. Date 2/28/2027.