Recall -- Firm Press Release
FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.
Life & More, L.L.C. Issues Nationwide Voluntary Recall of Akttive High Performance Fat Burner Gold Capsules Due to Undeclared Drug Ingredients
FOR IMMEDIATE RELEASE - July 23, 2015 - Miami, Florida - Life & More, L.L.C. is voluntarily recalling 783 Bottles from Lot #000185004400 Akttive High Performance Fat Burner Gold capsules weight loss supplements. The firm was informed by the US Food and Drug Administration (FDA) that a sample of Akttive High Performance Fat Burner Gold capsules was found to contain Sibutramine, desmethylsibutramine, 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 Sibutramine is an appetite suppressant that was withdrawn from the U.S. market in October 2010 (due to increased risk of seizures, heart attacks, arrhythmia and strokes).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 approved for marketing in the United States. These undeclared ingredients make this product an unapproved new drug for which safety and efficacy have not been established.
Products containing Sibutramine pose a threat to consumers because Sibutramine can increase blood pressure and/or pulse rate in some patients and may present a risk for those with a history of coronary artery disease, congestive heart failure or stroke. These products may also interact in life threatening ways with other medications a consumer may be taking. Health risks associated with phenolphthalein could include potentially serious gastrointestinal disturbances, irregular heartbeat, and cancer with long-term use. No illnesses or injuries have been reported to the company to date in connection with this product.
Akttive High Performance Fat Burner Gold weight loss supplement capsules are marketed as a dietary supplement for weight loss. Akttive High Performance Fat Burner Gold capsules are packaged in aluminum bottles containing 30 gold capsules per bottle and labeled with Lot #000185004400, UPC 859189005005, Expiration 12/17. The products were distributed from January 2012 until July 2015.
The product was sold directly to distributors and online to consumers at www.akttive.com and shipped to the following states: NV, FL, NY, AZ, MA, NJ, CA, MD, TX, VA and MI.
Life & More, L.L.C. is notifying its distributors and customers by letter and is arranging for return of all recalled products. Consumers should not consume Akttive High Performance Fat Burner Gold weight loss supplement Capsules and should return it immediately to the place of purchase.
Consumers with questions regarding this recall can contact Life & More, L.L.C. at 01157-300-487-0534 or e-mail firstname.lastname@example.org , Monday through Friday from 9:00am - 5:00pm EST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.
This recall is being conducted with the knowledge of the US Food and Drug Administration.
Photo: Product Labels
Recalled Product Photos Are Also Available on FDA's Flickr Photostream.