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U.S. Marshals seize $11 million in unapproved drugs

"None of these products have been proven safe or effective for their intended uses," the FDA said.
By Alex Cukan   |   May 16, 2014 at 4:26 PM   |   Comments

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MONTVALE, N.J., May 16 (UPI) -- U.S. Marshals seized more than $11 million worth of unapproved drugs marketed by Ascend Laboratories of Montvale, N.J. and distributed by Masters Pharmaceuticals, Inc. of Cincinnati.

Ascend Laboratories is a subsidiary of Alkem Laboratories, one of the top seven pharmaceutical companies in India. Alkem is a vertically integrated organization with 15 manufacturing plants located throughout India, of which four are U.S. Food and Drug Administration approved, the company's website said.

At the request of the U.S. Food and Drug Administration and the U.S. Attorney for the Southern District of Ohio, the U.S. Marshals seized:

-- Pramoxine-HC Otic Drops, intended to treat ear infections caused by microbes and to control itching.

-- Hydrocortisone Acetate Suppositories 25 milligrams, intended to treat inflamed hemorrhoids, ulcerative colitis and other inflammatory conditions.

-- 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 healthcare professional about the continuing use of these drug products," the FDA said in a statement.

"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 court action followed an inspection at Ascend Laboratories last November that allegedly found the marketing of drug products without an FDA-approved drug application and may pose risks to patients.

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