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FDA NEWS RELEASE
For Immediate Release
: Feb. 16, 2011
Media Inquiries: Christopher Kelly, 301-796-4676, christopher.kelly@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA


U.S. Marshals seize Auralgan Otic Solution
Product is not FDA-approved

U.S. Marshals, at the request of the U.S. Food and Drug Administration yesterday, seized all lots of Auralgan Otic Solution, a prescription drug used to treat pain and inflammation associated with ear infections, from Integrated Commercialization Solutions Inc. (ICS) in Brooks, Ky.  Auralgan is manufactured for Deston Therapeutics, located in Chapel Hill, N.C., and is warehoused at ICS. 

Deston’s sale of the product in the United States violates federal law because the product does not have FDA approval and its labeling does not include adequate directions for use.  The value of the products seized is estimated to be $16.5 million.

“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 the FDA’s Center for Drug Evaluation and Research. “We will remain vigilant in our efforts to protect consumers from unapproved products.”

On Feb. 5, 2010, the FDA issued a Warning Letter to Deston, citing the company for distributing unapproved new drugs and misbranded drugs.  The FDA also warned Deston that Auralgan was an unapproved new drug in April, June, and September 2010, and the company continued distributing the drug in violation of the Federal Food, Drug, and Cosmetic Act.

Today’s action is part of the FDA’s Unapproved Drugs Initiative, established in 2006 to get unapproved drugs either approved or off the market.

For more information:

February 5, 2010 Warning Letter to Deston Therapeutics, LLC

Unapproved Drugs: Drugs Marketed in the United States That Do Not Have Required FDA Approval

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