Low Pharmaceuticals OTC skin products seizure
This article was originally published in The Rose Sheet
Executive Summary
June 10 seizure of approximately $430,830 worth of products in retail packages and bulk drums was due to the fact that the products are new drugs and are misbranded, according to FDA's July 13 Enforcement Report. "The articles are not generally recognized by qualified experts as safe and effective for their intended uses and there are no approved applications in effect," FDA says. In addition, "some of the articles' labeling fails to bear the established name of the each active ingredient; and all of the articles' labeling fails to bear adequate directions for use," FDA notes. The order against Wallingford, CT-based Low Pharmaceuticals was filed in Connecticut district court May 19