Auralgan Otic Solution is a prescription drug used to treat pain and inflammation associated with ear infections.
According to the FDA, the sale of Auralgan in the US violates federal law and its labeling does not include adequate directions for use.
Although the FDA had issued warning letters to Deston regarding the distribution of unapproved new drugs and misbranded drugs, the company continued to distribute the drug in violation of the Federal Food, Drug, and Cosmetic Act.
FDA Center for Drug Evaluation and Research, Office of Compliance director Deborah Autor said the FDA is committed to taking enforcement action against companies marketing drugs that do not meet federal standards for safety, effectiveness, and quality.
"We will remain vigilant in our efforts to protect consumers from unapproved products," Autor said.