FDA: Over $11,185,000 Worth of Unapproved Drugs Seized From Ohio Distributor

At the request of the U.S. Food and Drug Administration, the U.S. Marshals have seized over $11,000,000 worth unapproved drugs from Ohio distributor.

The U.S. Marshals on the request of the federal regulators and the U.S. Attorney for the Southern District of Ohio have seized more than $11,185,000 worth of unapproved drug that was marketed by Ascend Laboratories of Montvale, N.J. and distributed by Masters Pharmaceuticals, Inc of Cincinnati, Ohio.

The unapproved drugs seized include Pramoxine-HC Otic Drops, intended to treat infections of the external ear caused by microbes and also to control itching. The Marshals have also seized Hydrocortisone Acetate Suppositories 25 mg that is meant to treat inflamed haemorrhoids, ulcerative colitis and other inflammatory conditions. The list even included Urea Cream-39 percent, Urea Cream-40 percent and Urea Lotion 40 percent that is used to treat skin-thickening conditions like dermatitis and eczema.

None of the above mentioned products have been proven safe for use or effective for their intended use. The federal regulators caution that customers using these products should consult a health care professional about the continuing use.

A complaint has been filed by the FDA 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 FDA plays an integral role helping to ensure the safety and effectiveness of drug products through a rigorous review and approval process," said Carol Bennett, acting director of the Office of Compliance in the FDA's Center for Drug Evaluation and Research. "Companies that disregard the law put the health of American consumers at risk."

This complaint follows the November 2013 inspection held at Ascend Lab's that revealed the marketing of drug products without an FDA approved drug application. 

This act of seizing products is consistent with the enforcement policy set in the FDA Marketed Unapproved Drugs Compliance Policy Guide which established that unapproved drug products first marketed after Sep 19, 2011 are subject to immediate enforcement action at any time without any notice.