Ben Venue Laboratories announced a nationwide recall of Roxane’s Acetylcysteine Solution 10%. The recall was initiated after a single glass particle was discovered in a vial. Acetylcysteine is a mucolytic agent indicated as adjuvant therapy for patients with abnormal, viscid, or inspissated mucous secretion.
The affected 30mL vials have Lot # 2005479, NDC # 0054-3025-02, and an expiration date of March 2014.
The inhalation of a product with glass particles can potentially cause choking, which may be life-threatening. Glass particles can also cause airway obstruction leading to symptoms of wheezing, difficulty breathing, coughing, and potentially hemoptysis. Further, aerosolization of small glass particles could result in recurring infections.
Healthcare professionals and healthcare facilities are to immediately quarantine any of the affected products for return.
For more information call (800) 962-8364 or visit the FDA Safety Alert Page.