Products found to contain undeclared medicines
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| The United States: REFA Enterprises, LLC Issues Voluntary Nationwide Recall of Forever Beautiful Bee Pollen Due to Undeclared Sibutramine and Phenolphthalein |
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The US Food and Drug Administration (FDA) announced that 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Sibutramine is an appetite suppressant that was withdrawn from the U.S. market in October 2010 (due to increased risk of seizures, heart attacks, arrhythmia and strokes).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. To date, the company has not received any reports of adverse events related to this recall.
All affected products are marketed as dietary supplements for weight loss. Forever Beautiful Bee Pollen is packaged in bottles of 60 capsules and was distributed via internet to consumers nationwide from July 7, 2014 – November 3, 2014. Forever Beautiful Infinity is packaged in bottles of 60 capsules and was distributed via internet to consumers nationwide from July 7, 2014 – November 3, 2014.
Consumers that have product which is being recalled should stop using and return products to REFA Enterprises, LLC. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/Recalls/ucm423908.htm
In Hong Kong, the above products are not registered pharmaceutical products.
Ends/ Thursday, November 20, 2014
Issued at HKT 13:00
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