Including Super Fat Burner Capsules, Maxi Gold Capsules, and Esmeralda Softgels
ISSUE: New Life Nutritional Center is recalling all lots of “Super Fat Burner capsules, Maxi Gold capsules and Esmeralda softgels” to the user level after FDA analysis revealed the products contain undeclared active pharmaceutical ingredients: sibutramine, phenolphthalein or a combination of both sibutramine and phenolphthalein.
Sibutramine is an appetite suppressant that was withdrawn from the U.S. market in October 2010 (due to increased risk of seizures, heart attacks, arrhythmia and strokes).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 United States. These undeclared ingredients make these products unapproved new drugs for which safety and efficacy have not been established.
BACKGROUND: These products are used as weight loss aids and are packaged in 30 capsule bottles. New Life Nutritional Center distributed these products to customers residing in NY, NJ, LA, TX, VA, and MA via retail stores and internet sales through their website at www.newlifenutritional.com.
RECOMMENDATION: New Life Nutritional Center is notifying its customers by letter. Customers are advised to immediately discontinue use of these products and should return the products immediately to New Life Nutritional Center 714 West 181st Street NY, NY 10033 for a refund.