Nov. 1, 2007 – Another $300,000 worth of drugs and dietary supplements have been seized by U.S. Marshals due to unsanitary manufacturing conditions.
Nov. 1, 2007 – Another $300,000 worth of drugs and dietary supplements have been seized by U.S. Marshals due to unsanitary manufacturing conditions. This event comes following the $71,000 worth of goods seized earlier in October.
The U.S. Food and Drug Administration (FDA) reports that U.S. Marshals seized products including NC Solution, an antifungal product and other drugs for human or animal use, dietary supplements and ingredients to make those products because some lacked FDA approval and all were maintained under grossly unsanitary conditions by General Therapeutics Corp., of St. Louis, Mo.
The FDA considers NC Solution to be a drug because it is intended for use in the diagnosis, cure or treatment of disease in people or animals. NC Solution is also a new drug because it is not generally recognized as safe and effective for its intended uses.
The FDA explained that before a new drug product may be legally marketed, it must be shown to be safe and effective and approved by the FDA. The company does not have approval for NC Solution.
According to the FDA press release, in August and September, FDA inspectors found that the company was still manufacturing drugs and dietary supplements under unsanitary conditions, including insects and rodent filth on and around manufacturing equipment, despite a warning by the FDA of serious violations in 1999. Following the 1999 inspection, a company official told the FDA in January, 2000, it would stop manufacturing drugs.
The FDA recommends that consumers who have any products manufactured by General Therapeutics, including NC Solution, consult their healthcare provider about discontinuing use and alert their doctors if they have experienced any adverse events that they suspect are related to the product’s use.
Catherine L. Hanaway, U.S. Attorney for the Eastern District of Missouri, filed the complaint requesting the seizure, and her office will continue to coordinate with the FDA to ensure proper disposal of the seized items.
The FDA’s action against the company is consistent with the agency’s initiative on unapproved drugs that pose potentially harmful risks to consumers.
- More than $300,000 of Drugs and Dietary Supplements Seized: Some lacked FDA approval, maintained under unsanitary conditions. November 1, 2007. Accessed November 2, 2007. View Press Release.