Products found to contain undeclared medicines
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| The United States: Bee Extremely Amazed LLC issues voluntary nationwide recall of various products distributed for weight loss due to undeclared drug ingredients including sibutramine and/or phenolphthalein |
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Bee Extremely Amazed LLC, Jewett, OH is voluntarily recalling various products marketed for weight loss to the consumer level due to findings of undeclared drug ingredients including sibutramine and/or phenolphthalein.
Sibutramine is an appetite suppressant that was withdrawn from the U.S. market in October 2010. Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke. 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. Health risks associated with phenolphthalein could include potentially serious gastrointestinal disturbances, irregular heartbeat, and cancer with long-term use. These products may also interact in life-threatening ways with other medications a consumer may be taking.
To date, Bee Extremely Amazed is not aware of any adverse event reports related to these products.
All lots of the following products marketed for weight loss are being recalled:
• Asset Bold Manufactured for Asset Descor 500 mg 60 capsules per bottle-color-red
• Asset Extreme Plus Manufactured for Asset Descor 500 mg 30 capsules per bottle-color-red and yellow
• Evolve Manufactured for 2637 E. Atlantic Blvd, Pompano Beach, Florida 33062 250 mg per capsule 60 capsules per bottle-color-green and white
• Infinity Manufactured for Floyd Nutrition 500 mg 30 capsules per bottle-color-red
• Jenesis Manufactured for Timeless Solutions 1810 E. Sahara Ave #100 Las Vegas, Nevada 89104 350 mg per capsule 60 capsules per bottle-color-blue
• La Trim Plus Manufactured for: MWN Health 37 N Orange Ave Suite 500 Orlando, FL 32801 (407) 930-4043 350 mg 60 Capsules
• Oasis Manufactured for MWN Health 37 N. Orange Ave Suite 500 Orlando, Fl, 32801 500 mg per capsule, 45 capsules per bottle-color-red
• Prime Manufactured for Zagonfly 3129 25th St #392 Columbus, Indiana 47203 500 mg per capsule, 60 capsules per bottle-color-red
• SlimeX-15 Manufactured in India by: HAB Pharmaceuticals & Research Limited 10-Pharma City, SIDCU?L, Selaqui, Dehradun, 248 197 15 mg 30 capsules per bottle–color-orange
• Slim Trim U Manufactured for Floyd Nutrition 250 mg 60 capsules per bottle-color-green and white
• Ultimate Formula Manufactured for Zi Xiu Tang 250 mg 48 capsules per bottle-color-green and white
• Xcel Manufactured for JNS Health 60 capsules per bottle-color-silver
• Xcel Advanced Manufactured for JNS Health 350 mg 60 capsules per bottle-color-gold
• Zi Xiu Tang 250 mg 60 capsules per bottle-color-green and white
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/Recalls/ucm478794.htm
In Hong Kong, the above products are not registered pharmaceutical products, and there is no registered pharmaceutical product manufactured by Bee Extremely Amazed LLC.
Ends/ Thursday, December 24, 2015
Issued at HKT 14:00
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