Unapproved Drugs Seized From Ohio Distributor At FDA Request

The U.S. Food and Drug Administration (FDA) and U.S. marshals seized more than $11 million worth of unapproved drugs last week.

The drugs were marketed by Ascend Laboratories of Montvale, New Jersey and distributed by Masters Pharmaceuticals, Inc. of Cincinnati, Ohio. Unapproved products include Pramoxine-HC Otic Drops meant to treat and control microbe-caused itching of the external ear; Hydrocortisone Acetate Suppositories 25 mg meant to treat inflamed hemorrhoids, ulcerative colitis, and other inflammatory conditions; Urea Cream 39 percent/40 percent and Urea Lotion 40 percent, meant as treatment for skin-thickening conditions, such as dermatitis and eczema.

The FDA clarified that none of the drugs were proved to be safe or effective for their intended indications. The agency suggests that the public consult healthcare professionals about continuing use of the unapproved products.

Carol Bennett, acting director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research, said, “The FDA plays an integral role helping to ensure the safety and effectiveness of drug products through a rigorous review and approval process. Companies that disregard the law put the health of American consumers at risk.”

A complaint from the FDA in the U.S. District Court for the Southern District of Ohio claiming that the drugs were unapproved and misbranded under the Federal Food, Drug, and Cosmetic Act resulted in the seizure. The FDA has previously conducted an inspection in November 2013 of Ascend Laboratories and discovered the commercialization of products lacking an FDA-approved application.

The FDA’s Marketed Unapproved Drugs Compliance Policy Guide, states that unapproved new drugs first commercialized after September 19, 2011 are subject to immediate enforcement action any time without requiring prior notice. The seizure is consistent with the agency’s enforcement policy and prevents the use of drugs which may be of uncertain quality and may pose health risks to consumers.