U.S. Marshals acting on a request of FDA seized all lots of Auralgan otic solution from Integrated Commercialization Solutions in Brooks, Ky.
U.S. Marshals acting on a request of FDA seized all lots of Auralgan otic solution from Integrated Commercialization Solutions (ICS) in Brooks, Ky. Auralgan, a prescription drug used to treat pain and inflammation associated with ear infections, was manufactured by Deston Therapeutics located in Chapel Hill, N.C. and warehoused by ICS.
This action is part of FDA’s Unapproved Drugs Initiative, established in 2006 to get unapproved drugs either approved or off the market.
“The FDA is committed to taking enforcement action against companies marketing drugs that do not meet federal standards for safety, effectiveness, and quality,” said Deborah M. Autor, director of the Office of Compliance in FDA’s Center for Drug Evaluation and Research. “We will remain vigilant in our efforts to protect consumers from unapproved products.”
Deston’s sale of Auralgan was not approved by FDA and its labeling did not include adequate directions for use. FDA repeatedly warned Deston last year that Auralgan was an unapproved new drug and that the company was violating the Federal Food, Drug, and Cosmetic Act by continuing its distribution. The value of Auralgan seized is estimated to be $16.5 million.