American Regent, Inc. — 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)

Official product recall notices and clearly labeled enforcement reference records.

Reference record — not a live warning · enforcement-reference · official-source

Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde

Provider: FDA — drug enforcement reference
Source observed: 8/26/2026, 12:00:00 AM UTC
Source updated: 8/26/2026, 12:00:00 AM UTC
Location: Shirley, NY, US
hazard: Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
notice: Periodic enforcement reference; not a real-time safety alert or a reliable recall-lifecycle tracker.
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.
distribution: Nationwide within the U.S
manufacturer: American Regent, Inc.
recall number: D-0798-2026
source status: Ongoing
classification: Class II
freshness minutes: 180

Source use policy · openFDA reference data; not a real-time public alert service

Update history (1 recent revisions)