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FDA warns of glass particles found in medical solution

This news story was published on March 15, 2014.
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WASHINGTON – Ben Venue Laboratories is recalling a lot of Acetylcysteine Solution 10 percent because a piece of glass particle was found in a vial. Acetylcysteine is used to help clear abnormal, thick or sticky mucous secretion. It is usually delivered as a mist via a Nebulizer, but can also be delivered through a tracheostomy (an opening in the windpipe) or bronchoscopy (an exploration of the lung’s airways). The recalled lots were manufactured for Roxane Laboratories, NDC #0054-3025-02, with lot number 2005479.

Risk: Glass particles can obstruct the airway, resulting in symptoms such as choking, wheezing, difficulty breathing, coughing and coughing up blood. Use of an inhaled product with glass particles has the potential to cause choking that could be life-threatening. Aerosolization of small glass particles in the airways could result in recurrent infections.

The FDA says consumers should not use the product lot listed above for patient care and should immediately return the product to their pharmacist or health care professional.

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