FDA Requests Unapproved Drugs to be Seized from Manufacturer by US Marshals

February 28, 2011 11:10 AM Topics: Prescriptions

As part of FDA’s Unapproved Drugs Initiative, US Marshals 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 on February 15, 2011. Auralgan is manufactured for Deston Therapeutics, located in Chapel Hill, NC, and is warehoused at ICS. The product does not have FDA approval and its labeling does not include adequate directions for use; thus, Deston’s sale of the product in the US violates federal law. The action followed several warnings sent by FDA to Deston in 2010, regarding the company’s distribution of unapproved new drugs and misbranded drugs, as reported in an FDA News Release.