Ben Venue Laboratories issues voluntary recall of acetylcysteine solution

Ben Venue Laboratories has initiated this voluntary recall on 14 February 2014 and has informed the US Food and Drug Administration (FDA) of its actions. The company is maintaining ongoing discussion with the agency.

Until now, no complaints or adverse events have been reported related to a piece of glass in vials of the lot 2005479. All other product parameters were within specifications.

The company is asking patients who received the product from this one lot to return it to their pharmacist.

Acetylcysteine is indicated as adjuvant therapy for patients with abnormal, viscid, or inspissated mucous secretion. It is indicated as an antidote to prevent or lessen hepatic injury that may occur following the ingestion of a potentially hepatotoxic quantity of acetaminophen.

Acetylcysteine for inhalation is usually delivered through a nebulizer, but can also be delivered via direct instillation into a tracheostomy, or into the bronchial-pulmonary tree during bronchoscopy.

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).

Image: Ben Venue Laboratories issues voluntary recall of acetylcysteine solution. Photo: Courtesy of Ben Venue Laboratories, Inc.