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FDA Medwatch Alert: Acetylcysteine Solution, USP (Roxane Laboratories, Inc.): Recall - Visible Glass Particle
Posted 3 Feb 2012 by Drugs.com
ISSUE: Bedford Laboratories issued an update to the voluntary recall, initiated December 20, 2011 of one lot of Acetylcysteine Solution (Roxane Laboratories) due to the discovery of a single visible glass particle in a vial within the lot. Glass particles can cause airway obstruction resulting in symptoms of choking, wheezing, difficulty breathing, coughing and potentially hemoptysis. Use of an inhaled product with glass particles has the potential to cause choking which could be life-threatening. Aerosolization of small glass particles in the airways could result in recurrent infections (due to obstruction of airways, and decreased clearance of airway secretions). BACKGROUND: The single lot is identified as Lot 1877093 – Exp. Date June 2013. Acetylcysteine is indicated as adjuvant therapy for patients with abnormal, viscid, or inspissated mucous secretion. Acetylcysteine, administered o ... Read more