Additionally, after FDA laboratory analysis found the same APIs, Toms River, NJ-based Pure Edge Nutrition, LLC voluntarily recalled lots of several products, including Bella Vi Insane Bee Pollen capsules, Bella Vi BTrim Ultimate Boost, Bella Vi BTrim Max, Bella Vi Extreme Accelerator, Bella Vi Insane Amp’d and Bella Vi Amp’d Up.
Sibutramine is an appetite suppressant that was withdrawn from the U.S. market in October 2010 due to increased risk of seizures, heart attacks, arrhythmia and strokes. Phenolphthalein is an ingredient previously used in over-the-counter laxatives, but because of concerns of carcinogenicity, it is not currently approved for marketing in the U.S. These undeclared ingredients make these products unapproved new drugs for which safety and efficacy have not been established.
No illnesses or injuries were reported at the time of recall in connection with either company’s products.
FDA also found that several products from Nova Products, Inc. of Aston, PA, tested positive for undeclared amounts of sildenafil and tadalafil, active ingredients of FDA-approved drugs used to treat erectile dysfunction. As a result, Nova Products recalled the following products: African Black Ant (Lot# 2006-000926), Black Ant (Lot# 2006-3627878), XZen Gold (Lot# 130310GL), ZXen Platinum (Lot# 130520PL), XZen 1200 (Lot# 13051012), XZone Gold (Lot# 131110GL), and XZone 1200 (Lot# 13071012).
These undeclared active ingredients pose a threat to consumers because they can interact with nitrates found in some prescription drugs (such as nitroglycerin), resulting in decreased blood pressure. Prescription drugs containing nitrates are frequently prescribed for individuals with diabetes, high blood pressure, high cholesterol or heart disease.
These products are marketed as dietary supplements for sexual enhancement and packaged in blister packs, envelopes, bottles, and/or boxes distributed to consumers nationwide at retail stores.
Meanwhile, GlaxoSmithKline (GSK) Consumer Healthcare voluntarily recalled all alli weight loss products from U.S. and Puerto Rico retailers as the company believed some packages of the product were tampered with and may contain product that is not authentic alli. GSK said it is conducting an investigation and is working with FDA on the retailer level recall. GSK received inquiries from consumers in seven states about bottles of alli that contained tablets and capsules that were not alli. A range of tablets and capsules of various shapes and colors were reported to be found inside bottles. Additionally, some bottles inside the outer carton were missing labels and had tamper-evident seals that were not authentic. These tampered products were purchased in retail stores. “We are committed to finding out what happened and to doing everything possible to prevent future issues with alli,” said Colin Mackenzie, president of Consumer Healthcare North America. “We regret any inconvenience caused by this retailer recall.”