US Marshals Seize $11 Million in Drugs from Ascend Labs
May 21st, 2014 // 2:54 pm @ jmpickett
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 FDA 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 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.
