03.28.14
New Life Nutritional Center, New York, NY, 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.
Similarly, Toms River, NJ-based Pure Edge Nutrition, LLC is voluntarily recalling one lot of each: 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 two lots of Bella Vi Amp’d Up to the consumer level. The products were also found to contain undeclared sibutramine or a combination of both sibutramine and phenolphthalein through FDA laboratory analyses.
Sibutramine is an appetite suppressant that was withdrawn from the U.S. market in October 2010 due to increased risk of seizures, heart attacks, arrhythmia and strokes.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.
At this time no illnesses or injuries have been reported to New Life Nutritional Center or Pure Edge Nutrition in connection with these products.
New Life Nutritional Center’s products are used as weight loss aids and are packaged in 30 capsule bottles. All lots of these products are being recalled. The company distributed these products to customers residing in NY, NJ, LA, TX, VA, and MA via retail stores and internet sales through their website. It is notifying its customers of the recall 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. Consumers with questions should contact Nilson Rosado at 646-209-9846 Monday – Friday 8:00 AM to 6:00 PM EST or via e-mail at rosadohow@aol.com.
Pure Edge Nutrition’s products were also marketed as dietary supplements for weight loss, and were packaged and distributed as follows:
· Bella Vi Insane Bee Pollen Capsules is packaged in bottles of 60 capsules with lot # 201303 EXP: 14/03/07. Bella Vi Insane was distributed to consumers and distributors nationwide from March 1, 2013 – August 31, 2013.
· Bella Vi BTrim Max is packaged in bottles of 60 capsules with lot # BTX13 EXP: 2015/08/15. Bella Vi Btrim Max was distributed to consumers and distributors nationwide from August 31, 2013 – September 31, 2013.
· Bella Vi BTrim Ultimate Boost is packaged in bottles of 30 capsules with lot # BTRM3452 EXP: 2015/07/03. Bella Vi Btrim was distributed to consumers and distributors nationwide from July 1, 2013 – September 31, 2013.
· Bella Vi Extreme Accelerator is packaged in bottles of 30 capsules with lot # BTRX7654 EXP: 2015/07/08. Bella Vi Extreme was distributed to consumers and distributors nationwide from July 1, 2013 – September 31, 2013.
· Bella Vi Insane Amp’d is packaged in bottles of 60 capsules with lot # VINA2013 EXP: 2015/06/12. Bella Vi Insane Amp’d was distributed to consumers and distributors nationwide from June 1, 2013 – September 31, 2013.
· Bella Vi Amp’d Up is packaged in bottles of 60 capsules with lot # AU2013AB EXP: 2015/05/20 and lot #BVAU813 EXP: 2015/08/12. Bella Vi Amp’d Up was distributed to consumers and distributors nationwide from May 1, 2013 – September 31, 2013.
Pure Edge Nutrition, LLC is notifying its distributors and customers by email and is arranging for return of all recalled products. Consumers and distributors that have products that are being recalled should stop usage and return products to Pure Edge Nutrition, LLC. Consumers with questions regarding this recall can contact Pure Edge Nutrition, LLC at (888) 417-3613 Monday – Friday 10:00 AM – 2:00 PM EST or email info@pureedgenutrition.com.
All consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these drug products.
Adverse reactions or quality problems experienced with the use of any of these products may be reported to FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax to 1-800-FDA-0178.
Similarly, Toms River, NJ-based Pure Edge Nutrition, LLC is voluntarily recalling one lot of each: 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 two lots of Bella Vi Amp’d Up to the consumer level. The products were also found to contain undeclared sibutramine or a combination of both sibutramine and phenolphthalein through FDA laboratory analyses.
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.
At this time no illnesses or injuries have been reported to New Life Nutritional Center or Pure Edge Nutrition in connection with these products.
New Life Nutritional Center’s products are used as weight loss aids and are packaged in 30 capsule bottles. All lots of these products are being recalled. The company distributed these products to customers residing in NY, NJ, LA, TX, VA, and MA via retail stores and internet sales through their website. It is notifying its customers of the recall 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. Consumers with questions should contact Nilson Rosado at 646-209-9846 Monday – Friday 8:00 AM to 6:00 PM EST or via e-mail at rosadohow@aol.com.
Pure Edge Nutrition’s products were also marketed as dietary supplements for weight loss, and were packaged and distributed as follows:
· Bella Vi Insane Bee Pollen Capsules is packaged in bottles of 60 capsules with lot # 201303 EXP: 14/03/07. Bella Vi Insane was distributed to consumers and distributors nationwide from March 1, 2013 – August 31, 2013.
· Bella Vi BTrim Max is packaged in bottles of 60 capsules with lot # BTX13 EXP: 2015/08/15. Bella Vi Btrim Max was distributed to consumers and distributors nationwide from August 31, 2013 – September 31, 2013.
· Bella Vi BTrim Ultimate Boost is packaged in bottles of 30 capsules with lot # BTRM3452 EXP: 2015/07/03. Bella Vi Btrim was distributed to consumers and distributors nationwide from July 1, 2013 – September 31, 2013.
· Bella Vi Extreme Accelerator is packaged in bottles of 30 capsules with lot # BTRX7654 EXP: 2015/07/08. Bella Vi Extreme was distributed to consumers and distributors nationwide from July 1, 2013 – September 31, 2013.
· Bella Vi Insane Amp’d is packaged in bottles of 60 capsules with lot # VINA2013 EXP: 2015/06/12. Bella Vi Insane Amp’d was distributed to consumers and distributors nationwide from June 1, 2013 – September 31, 2013.
· Bella Vi Amp’d Up is packaged in bottles of 60 capsules with lot # AU2013AB EXP: 2015/05/20 and lot #BVAU813 EXP: 2015/08/12. Bella Vi Amp’d Up was distributed to consumers and distributors nationwide from May 1, 2013 – September 31, 2013.
Pure Edge Nutrition, LLC is notifying its distributors and customers by email and is arranging for return of all recalled products. Consumers and distributors that have products that are being recalled should stop usage and return products to Pure Edge Nutrition, LLC. Consumers with questions regarding this recall can contact Pure Edge Nutrition, LLC at (888) 417-3613 Monday – Friday 10:00 AM – 2:00 PM EST or email info@pureedgenutrition.com.
All consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these drug products.
Adverse reactions or quality problems experienced with the use of any of these products may be reported to FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax to 1-800-FDA-0178.
