Ben Venue recalls inhaled drug because of glass fragment: Food and Drug recalls

CLEVELAND, Ohio-- Bedford-based Ben Venue Laboratories is recalling one lot of an inhaled drug solution used in nebulizers because a glass particle was found in a vial of the drug, the company said Friday. Ben Venue, which shut down its production at the end of 2013, has been plagued by quality and safety issues over the past three years.


The drug, acetylcysteine, is used in solution for inhalation and is most often delivered via a nebulizer. It is used to treat chronic bronchitis and chronic obstructive pulmonary disease (COPD), as well as some cancers, epilepsy, and counteracting Tylenol and carbon monoxide poisoning.


Use of the product can be life-threatening, because inhaled glass particles can cause airway obstruction, leading to choking, wheezing, difficulty breathing, coughing, and coughing up blood. Airway obstruction in susceptible individuals can also cause infection. There have not yet been any reports of injuries or adverse events from the use of the medication, according to the release.


Patients who may have received the affected drug, with lot number 2005479 and an expiration date of March 2014, should return it to their pharmacist. For more information about the recall, call GENCO Pharmaceutical Services at 1-800-633-1422 .


http://www.cleveland.com/healthfit/index.ssf/2014/02/ben_venue_recalls_inhaled_drug.html