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US marshals seize unapproved dermatitis, eczema products
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US marshals have seized more than $11 million worth of unapproved drugs, including creams and lotions intended to treat dermatitis and eczema, at the request of the FDA and the US Attorney for the Southern District of Ohio.
The unapproved drugs were marketed by Ascend Laboratories of Montvale, N.J., and distributed by Masters Pharmaceuticals of Cincinnati, according to an FDA press release. The products include Urea Cream 40%, Urea Cream 39% and Urea Lotion 40%, intended to treat dermatitis and eczema; Pramoxine-HC Otic Drops, to treat external ear infections caused by microbes and to control itching; and Hydrocortisone Acetate Suppositories 25 mg, for hemorrhoids and ulcerative colitis.
The FDA recommended that consumers consult a health care professional about continued use of the products, which have not been proven safe or effective, according to the release.
A complaint filed by the FDA in US District Court for the Southern District of Ohio alleged “the products are unapproved and misbranded drugs under the Federal Food, Drug, and Cosmetic Act.” A November inspection at Ascend Laboratories revealed marketing of drug products without an FDA-approved application, the release said.
“The FDA plays an integral role helping to ensure the safety and effectiveness of drug products through a rigorous review and approval process,” Carol Bennett, acting director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research, said in the release. “Companies that disregard the law put the health of American consumers at risk.”