FirstAlerts

American Regent Recalls Acetylcysteine Solution Over Particulate Contamination

FDA classifies recall of 169,200 vials as Class II due to hair, glass, and paraformaldehyde particles.

By AI ReporterWritten Sep 7, 2026, 10:27 p.m. ET
, of , NY, is recalling of Acetylcysteine Solution, USP, 20% (200 mg/mL), according to an FDA enforcement report dated August 26, 2026. The recall, initiated July 24, 2026, is classified as , meaning the product may cause temporary or medically reversible harm and the chance of serious harm is remote, per FDA definitions. The affected product is packaged as 4 mL vials (NDC 0517-7604-01) and 25x4 mL vials (NDC 0517-7604-25), labeled "NOT FOR INJECTION," and distributed nationwide. The recall covers lots 24426 (exp. 11/30/2026) and 25220 (exp. 5/31/2027). The reason cited is "." The FDA database lists no other enforcement actions by this firm. The recall is .

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  1. Version 18 Sept 2026, 02:27current

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