American Regent, Inc. — ACETYLCYSTEINE SOLUTION, USP, 10% (100 mg/mL), packaged in a) 4 mL Vial NOT FOR INJECTION (NDC 0517-7504-01), and b) 25x4 mL Vials NOT FOR INJECTION (NDC 0517-7504-25), Rx Only, AM

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: ACETYLCYSTEINE SOLUTION, USP, 10% (100 mg/mL), packaged in a) 4 mL Vial NOT FOR INJECTION (NDC 0517-7504-01), and b) 25x4 mL Vials NOT FOR INJECTION (NDC 0517-7504-25), Rx Only, AMERICAN REGENT, INC., SHIRLEY, NY 11967.
distribution: Nationwide within the U.S
manufacturer: American Regent, Inc.
recall number: D-0796-2026
source status: Ongoing
classification: Class II
freshness minutes: 180

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

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