Forever Beautiful Bee Pollen by REFA Enterprises: Recall - Undeclared Drug Ingredients
Audience: Consumer
[Posted 11/20/2014]
ISSUE: REFA Enterprises is voluntarily recalling one lot each of:
Forever Beautiful Bee Pollen (UPC # 6333090804632)
Forever Beautiful Infinity (UPC # 633090804649)
The products have been found to contain undeclared Sibutramine or a combination of both Sibutramine and Phenolphthalein through FDA laboratory analyses.
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, arrhymias 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.
BACKGROUND: Sibutramine is an appetite suppressant that was withdrawn from the U.S. market in October 2010 due to increased risk of seizures, heart attacks, arrhythmia and strokes.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.
Forever Beautiful Bee Pollen and Forever Beautiful Infinity are packaged in bottles of 60 capsules, and were distributed via internet to consumers nationwide from July 7, 2014 – November 3, 2014.
RECOMMENDATION: Consumers that have recalled product should stop using them, and return products to REFA Enterprises, LLC.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.accessdata.fda.gov/scripts/medwatch/index.cfm
- Download form 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
[11/19/2014 - Press Release - REFA Enterprises]
[11/19/2014 - Product Photos - FDA]
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