U.S. Marshals seized all lots of Auralgan Otic Solution from a Deston warehouse in Brooks, Ky., Feb. 16. Auralgan is a prescription drug used to treat pain and inflammation associated with ear infections.
The FDA said that selling Auralgan violates the law because Deston’s product does not have FDA approval and its labeling does not include adequate directions for use.
“The FDA is committed to taking enforcement action against companies marketing drugs that do not meet federal standards for safety, effectiveness and quality,” Deborah Autor, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research said in a prepared statement. “We will remain vigilant in our efforts to protect consumers from unapproved products.”
Calls to Deston were not returned. The FDA last February sent Deston a warning letter that cited the company for distributing “unapproved new drugs and misbranded drugs.” The FDA followed with warnings in April, June and September that Auralgan was unapproved. The FDA said that its actions on Deston are part of an initiative started in 2006 to get unapproved drugs approved or off the market.