Official recall notice

FDA DrugClass IINotable

Acetylcysteine Solution Recall (Aug 2026) – American Regent

Product: ACETYLCYSTEINE SOLUTION, USP, 20% (200 mg/mL), packaged in a) 4 mL Vial NOT FOR INJECTION (NDC 0517-7604-01), and b) 25x4 mL Vials NOT FOR INJECTION (NDC 0517-7604-25), Rx only, AMERICAN REGENT, INC., SHIRLEY, NY 11967.

Recall date
2026-08-26
Category
Drug
FDA class
Class II

Why it was recalled

Hazard

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

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Product description

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

Affected products

Lot #: 24426, Exp. Date: 11/30/2026; 25220, Exp. Date: 5/31/2027.

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