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acetylcysteine FDA Alerts

The FDA Alert(s) below may be specifically about acetylcysteine or relate to a group or class of drugs which include acetylcysteine.

MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings. For the latest FDA MedWatch alerts, go here.

Recent FDA Alert(s) for acetylcysteine

Acetylcysteine Solution 10 Percent: Recall - Glass Particles in Product

Feb 15, 2014

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.

 

[02/14/2014 - Press Release - Ben Venue Laboratories ]

Acetylcysteine Solution, USP (Roxane Laboratories, Inc.): Recall - Visible Glass Particle

Feb 3, 2012

Audience: Risk Manager, Pulmonology, Patient

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 orally, is indicated as an antidote to prevent or lessen hepatic injury which may occur following the ingestion of a potentially hepatotoxic quantity of acetaminophen. Acetylcysteine for inhalation is usually delivered via a Nebulizer, but can also be delivered via direct instillation into a tracheostomy, or into the bronchial-pulmonary tree during bronchosopy.

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 that may have received product dispensed from this one lot should return the product to their pharmacist.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

 

[02/02/2012 - Press Release - Bedford Laboratories]

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