REFA Enterprises, LLC is voluntarily recalling one lot of each: Forever Beautiful Bee Pollen (UPC # 6333090804632), Forever Beautiful Infinity UPC # 633090804649), to the consumer level. The products have been 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 Sibutramine is an appetite suppressant that was withdrawn from the U.S. market in October 2010 (due to increased risk of seizures, heart attacks, arrhythmia and strokes).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 United States. These undeclared ingredients make these products unapproved new drugs 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, arrhythmias 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.
All affected products are marketed as dietary supplements for weight loss and were packaged and distributed as follows:
Forever Beautiful Bee Pollen is packaged in bottles of 60 capsules, Forever Beautiful Bee pollen was distributed via internet to consumers nationwide from July 7, 2014 – November 3, 2014.
Forever Beautiful Infinity is packaged in bottles of 60 capsules. Forever Beautiful Infinity was distributed via internet to consumers nationwide from July 7, 2014 – November 3, 2014.
REFA Enterprises, LLC is notifying its customers by email and is arranging for return of all recalled products. Consumers that have product which is being recalled should stop using and return products to REFA Enterprises, LLC.
Consumers with questions regarding this recall can contact REFA Enterprises, LLC at (757) 420-1122 Monday – Friday 12:00 p.m. – 6:00 p.m. EST or email firstname.lastname@example.org.
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 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 U.S. Food and Drug Administration.