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U.S. Marshals, at the request of the U.S. Food and Drug Administration and the U.S. Attorney for the Southern District of Ohio, have seized more than $11,185,000 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 recommends that consumers consult a health care professional about the continuing use of these drug products.
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 new drug approval process plays an essential role in ensuring that all drugs are safe and effective for their intended uses. Unapproved new drugs have not been shown to be safe and effective, may be of uncertain quality and do not have FDA-approved labeling; as a result, these drugs may pose risks to patients.
“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.”
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.
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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.