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Acetylcysteine Solution 10 Percent: Recall - Glass Particles in Product
AUDIENCE: Pharmacy, Risk Manager, Pulmonology
ISSUE: Ben Venue Laboratories notified health professionals and their medical care organizations of a nationwide product recall of Acetylcysteine Solution 10%, manufactured for Roxane Laboratories, NDC #0054-3025-02 – Lot 2005479 – Exp. Date March 2014. The recall was initiated on February 14, 2014 after the discovery of a single visible glass particle in a vial within the lot listed above. The nationwide voluntary recall is to the patient level. This recall is limited to lot number 2005479.
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: Acetylcysteine is indicated as adjuvant therapy for patients with abnormal, viscid, or inspissated mucous secretion. It is usually delivered via a Nebulizer, but can also be delivered via direct instillation into a tracheostomy, or into the bronchial-pulmonary tree during bronchoscopy.
RECOMMENDATION: Hospitals, emergency rooms, clinics, physician offices and other healthcare facilities and providers should not use the product lot listed above for patient care and should immediately quarantine any product for return. Patients who may have received product dispensed from this one lot should return the product to their pharmacist. Distributors/retailers that have not received a recall packet should contact GENCO Pharmaceutical Services, 6101 North 64th Street, Milwaukee, WI 53218.
Read the MedWatch safety alert, including a link to the Press Release, at:
You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm
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