Reason: Marketed Without An Approved NDA/ANDA: FDA analysis of this product found it to contain undeclared steroids and steroid-like substances making this an unapproved new drug.
Distributed: Approximately 30% of all finished products were sold to customers in interstate to include but may not be limited to NY, NJ & CT via UPS. Products are promoted and sold directly to customers at Healthy Life Chemistry's retail store at 13A Lucon Drive in Deer Park, NY, on the company website (www.purityfirst.com), and are available at the health food store, Total Health, located at 120 Rte 110, Farmingdale, NY (www.totaldiscountvitamins.com).Reason: Marketed Without An Approved NDA/ANDA: FDA analyses detected the presence of phenolphthalein, N-di-Desmethylsibutramine, and trace amounts of sibutramine and N-Desmethylsibutramine. Sibutramine and phenolphthalein were previously available drug products but were removed from the U.S. market making these products unapproved new drugs.
Distributed: Nationwide, Puerto Rico, and internet salesReason: Marketed Without An Approved NDA/ANDA: FDA analysis detected the presence of sibutramine, N-Desmethylsibutramine and phenolphthalein. Sibutramine and phenolphthalein were previously available drug products but were removed from the U.S. market making these products unapproved new drugs.
Distributed: Nationwide, Puerto Rico, and internet salesReason: Marketed Without An Approved NDA/ANDA: Products were found to contain undeclared sibutramine, the active ingredient in a previously approved FDA product indicated for weight loss but removed from the market for safety reasons, making these products unapproved new drugs.
Distributed: Nationwide and Canada to distributors and consumers.Reason: Marketed Without An Approved NDA/ANDA: Products were found to contain undeclared sibutramine, the active ingredient in a previously approved FDA product indicated for weight loss but removed from the market for safety reasons, making these products unapproved new drugs.
Distributed: Nationwide and Canada to distributors and consumers.Reason: Lack of Assurance of Sterility; Drug product leaking from container therefore sterility cannot be assured
Distributed: NationwideReason: Presence of Foreign Substance; heavy metals (chromium, titanium etc) and inactive components of the product were visually observed during routine stability testing
Distributed: NationwideReason: Labeling: Not Elsewhere Classified; Due to an error in the manufacturing procedure, a cylinder in liquid withdrawal service was not marked Syphon Tube indicating liquid withdrawal and shipped as a gas withdrawal cylinder.
Distributed: Kansas, Missouri, and Arkansas.Reason: Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl alcohol content is 20%.
Distributed: NationwideReason: Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl alcohol content is 20%.
Distributed: Nationwide