Unapproved Drugs Seized by US Marshals at Request of FDA

At the request of FDA and the United States Attorney for the Southern District of Ohio, US Marshals have seized more than $11 million worth of unapproved drugs, indicates an FDA press release. The drugs were marketed by Ascend Laboratories of Montvale, NJ and held by Masters Pharmaceuticals, Inc, of Cincinnati, OH. The products include pramoxine-HC otic drops, hydrocortisone acetate suppositories, urea cream 40%, and urea lotion 40%.

Following a November 2013 inspection at Ascend Laboratories that revealed the marketing of drug products without FDA approval, FDA filed a complaint with the US District Court that ultimately resulted in this action. FDA notes that the seizure of these products is consistent with the agency’s enforcement policy as detailed in FDA’s Marketed Unapproved Drugs – Compliance Policy Guide.