ST. LOUIS (CN) – Members of the U.S. Food and Drug Administration and the U.S. Marshal’s Service seized $24.2 million worth of unapproved drugs from KV Pharmaceutical Company of St. Louis. The seizure followed an FDA inspection of KV’s plants earlier this year.
The inspections found that KV was not complying with an enforcement notice that drugs in time-release format with guaifenesin, an expectorant, must by approved by the FDA to ensure the safe release of the active ingredients. Inspectors also found that the company was manufacturing and distributing other unapproved new drugs for cough, cold, topical wound healing, skin bleaching, and gastrointestinal conditions.
“American consumers are entitled to have safe and effective drugs,” United States Attorney Catherine L. Hanaway said in a statement. “The majority of the products being seized were made after the FDA required an end to their production.”