FDA Seizes $11 Million Worth of Unapproved Drugs from Ascend Laboratories

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 05-19-2014 10:55

US Marshals, at the request of FDA and the US.Attorney for the Southern District of Ohio, have seized more than $11,185,000 worth of unapproved drugs marketed by Ascend Laboratories of Montvale, New Jersey. and distributed by Masters Pharmaceuticals, Inc. of Cincinnati, Ohio.

The seized products include: pamoxine-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 recommends that consumers consult a health care professional about the continuing use of these drug products.

FDA filed a complaint in the US 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.

Source: FDA


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