According to the FDA’s latest update on the ongoing acetylcysteine inhalation solution shortage, all of American Regent/Luitpold’s product is still on back order due to “manufacturing delays,” and the company is still unable to estimate a release date for any inhalation solution. The company’s Shirley, NY facility was shut down in April 2011 over safety concerns. American Regent resumed shipping many of its injectable products in May, but has subsequently issued voluntary recalls for many of those products.
Two other suppliers are anticipating shipments before the end of the year. Hospira expects to deliver 30 ml vials of both 100 mg/ml and 200 mg/ml solutions in October, and Roxanne Laboratories expects to release product for emergency shipments of 10 ml vials of 100 mg/ml and 200 mg/ml solutions in December. Roxanne also anticipates release of 30 ml vials of both concentrations for emergency shipment in January 2012.
See the FDA report.
