The recall, announced last Friday, comes after the company discovered a single visible glass particle in a vial within one lot. There have been no complaints or adverse events related to a piece of glass in vials of this lot, which was manufactured for Roxane Laboratories. All other product parameters were within specifications, according to the company.
Acetylcysteine is indicated as adjuvant therapy for patients with abnormal, viscid, or inspissated mucous secretion. Patients who may have received product dispensed from Lot 2005479 should return the product to their pharmacist, according to the FDA.
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 bronchoscopy. “Glass particles can cause airway obstruction resulting in symptoms of choking, wheezing, difficulty breathing, coughing and potentially hemoptysis,” the company said in a recall notice .
The announcement of the glass particles comes as Ben Venue announced in October that it would close and lay off all of its employees. The company also announced shortages of Doxil because of these manufacturing issues.
Ben Venue spokeswoman Kathy Vincent told Outsourcing-pharma.com that the contract manufacturing organisation (CMO) ceased production in December but she would not elaborate on the previously announced layoffs. She said this latest recall is part of the standard regulatory process.
Problems with the CMO, however, date back to 2011 , when the company announced it would voluntarily suspend manufacturing at this Ohio plant.
“Use of an inhaled product with glass particles has the potential to cause choking which could be life-threatening,” the company said in its letter to physicians. “Aerosolization of small glass particles in the airways could result in recurrent infections (due to obstruction of airways, and decreased clearance of airway secretions).”