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Sibutramine is an appetite suppressant that was withdrawn from the U.S. market in October 2010.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 undeclared ingredients make these products unapproved new drugs for which safety and efficacy have not been established. 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
Bee Extremely Amazed LLC is notifying its customers to stop using these products immediately and dispose of or return all recalled products to Bee Extremely Amazed 85205 Sportsmans Club Road Jewett Ohio 43986.
Consumers with questions regarding this recall can contact Bee Extremely Amazed by email to firstname.lastname@example.org or 1-844-427-6553 Monday - Friday 8:00 am - 4:00 pm EST. Consumers should contact their physician or healthcare provider if they have any health questions or 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.
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