Over $11 million worth of unapproved drugs have been seized by the U.S. marshals per request of the FDA and the U.S. Attorney for the Southern District of Ohio.
The unapproved drugs were marketed by Ascend Laboratories of Montvale, NJ, and distributed by Masters Pharmaceuticals of Cincinnati, OH. The FDA alleged that the products were unapproved and misbranded after a November 2013 inspection at Ascend Laboratories that revealed the marketing of these products without an FDA-approved drug application.
The affected products include:
- Pramoxine-HC Otic Drops– for external ear infections and itching
- Hydrocortisone Acetate Suppositories 25mg– for inflamed hemorrhoids, ulcerative colitis, and other inflammatory conditions
- Urea Cream 39% and 40%–for skin-thickening conditions (eg, dermatitis, eczema)
- Urea Lotion 40%–for skin-thickening conditions (eg, dermatitis, eczema)
None of the mentioned products have been proven safe or effective for their intended uses. Without an FDA-approved labeling, the drugs may pose a health risk to patients.
For more information call (888) 463-6332 or visit FDA.gov.