May 202011

The FDA has announced a shortage of acetylcysteine inhalation solution in the US due to increased demand and manufacturing delays. Acetylcysteine is a mucolytic agent.

According to the FDA web site, two manufacturers, Hospira and Roxanne Laboratories are experiencing shortages of 200 mg/ml vials as a result of increased demand and expect to release new product by the end of May, with Hospira expecting recovery by July.

American Regent/Luitpold is listed as having backorders for 100 and 200 mg/ml solutions due to “manufacturing delays.” Luitpold recently shut down all manufacturing at its Shirley, NY facility after a meeting with the FDA. According to the shortage report, “the company cannot estimate a release date.”

See the FDA report.