FDA Seizez over $300,000 Worth of Unapproved Products

09 Mar FDA Seizez over $300,000 Worth of Unapproved Products

The FDA notified healthcare professionals of the seizure of more than $300,000 worth of product, including NC Solution, an antifungal product, and other drugs for human 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. NC Solution is considered a drug because it is intended for use in the diagnosis, cure, or treatment of disease in people or animals and is not generally recognized as safe and effective for its intended uses. The company does not have FDA approval for NC Solution.

Consumers who have any products manufactured by General Therapeutics, including NC Solution, should consult their healthcare provider about discontinuing their use and report if they have experienced any adverse events that they suspect are related to the use of these products.

Read the official FDA newsletter at:
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01736.html