US Marshals, at the request of FDA and the US Attorney for the Southern District of Ohio, have seized more than $11 million worth of unapproved drugs marketed by Ascend Laboratories of Montvale, N.J. and distributed by Masters Pharmaceuticals, Inc. of Cincinnati, Ohio.
The seized products include: Pramoxine-HC Otic Drops, intended to treat infections of the external ear caused by microbes and to control itching; Hydrocortisone Acetate Suppositories 25 mg, intended to treat inflamed hemorrhoids, ulcerative colitis and other inflammatory conditions; and Urea Cream 39%, Urea Cream 40% and Urea Lotion 40%, intended to treat skin-thickening conditions such as dermatitis and eczema.
None of these products have been proven safe or effective for their intended uses. The FDA filed a complaint in the U.S. District Court for the Southern District of Ohio alleging that the products are unapproved and misbranded drugs under the Federal Food, Drug, and Cosmetic Act.
The complaint follows a November 2013 inspection at Ascend Laboratories that revealed the marketing of drug products without an FDA-approved drug application.
The seizure of these products is consistent with the enforcement policy set forth in the FDA’s Marketed Unapproved Drugs Compliance Policy Guide, which established that unapproved new drug products first marketed after Sept. 19, 2011 are subject to immediate enforcement action at any time without prior notice.