Recalls

Glass particles found in inhaled respiratory treatment

nose 2 Glass particles found in inhaled respiratory treatmentBen Venue Laboratories has issued a nationwide recall of an inhaled Acetylcysteine solution to treat specific respiratory conditions because of the possibility of glass particles in the solution. Inhaling these particles can cause airway obstruction that can lead to choking, wheezing, difficulty breathing, coughing and possibly hemoptysis, or blood in the mucus. These problems can be life threatening and could also result in recurrent infections due to obstruction of airways and decreased clearance of airway secretions.

Acetylcysteine is a drug that is inhaled to clear mucus and material entrapped in mucus in people who have thick mucus that may interfere with breathing or other functions, such as those with COPD, cystic fibrosis, pneumonia, and those in tracheostomy care. It is usually deliver via a breathing device known as a Nebulizer, but can also be delivered via direct instillation into a tracheostomy, or into the bronchial-pulmonary tree during bronchoscopy.

The nationwide recall affects Acetylcysteine Solution 10% manufactured for Roxane Laboratories, NDC #0054-3025-02 – Lot 2005479 – Exp. Date March 2014. The recall was issued on February 14, 2014, after the discover of a single visible glass particle in a vial within the lot listed above.

Hospitals, emergency rooms, clinicals, physician offices, and other health care facilities and providers should not use products from the affected lot and should immediately quarantine any of the recalled products in their possession for return. Patients who have received the drug dispensed from this lot should return it to their pharmacist.

Any health problems resulting from use of this product should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.

Source: FDA