The U.S. Food and Drug Administration (FDA) just announced that it informed Globe All Wellness, LLC that its Slim Xtremeâ„¢ Herbal Slimming Capsule weight loss dietary supplementâ€”sold by a seller not authorized by Globe All Wellness, LLC to sell the productâ€”contains an undeclared drug ingredient. FDA lab analyses of the dietary supplement found that the product contains undeclared Sibutramine. Because the FDA has not approved Sibutramine, the safety and efficacy of the recalled Slim Xtremeâ„¢ Herbal Slimming Capsule is unknown.
Sibutramine was marketed as <"http://www.yourlawyer.com/topics/overview/meridia">Meridia, a drug no longer available in the U.S. The manufacturer stopped producing the drug based clinical study data that found that those taking Sibutramine suffered an increased risk of cardiovascular events, including heart attack and stroke, PubMedHealth explained.
The FDA noted that all lots of the dietary supplement Slim Xtremeâ„¢ Herbal Slimming Capsule, which is delivered in 30 Capsules/Bottles, are being recalled. The recalled Slim Xtremeâ„¢ Herbal Slimming Capsule were sold and distributed nationwide via the Internet and at the companyâ€™s headquarters in Hollywood, Florida.
The FDA states that the recalled Slim Xtremeâ„¢ Herbal Slimming Capsule poses a threat to consumers because 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.
To date, no illnesses or injuries have been reported to Globe All Wellness, LLC in connection with this product and this recall does not affect the sales and distribution of Globe All Wellness, LLCâ€™s other products.
Consumers are advised to return the recalled Slim Xtremeâ„¢ Herbal Slimming Capsule to: Globe All Wellness, LLCâ€¨2854 Stirling Rd Suite Gâ€¨Hollywood, Florida, 33020. Globe All Wellness can also be reached at 1.954.922.1133, Monday through Friday, from 9:00 a.m. to 4:00 p.m., Eastern Standard Time (EST), for instructions on the return process.
Any adverse reactions experienced with the use of this product should also be reported to the FDAâ€™s MedWatch Program by telephone at 1-800-FDA-1088; by fax at 1-800-FDA-0178; by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, Maryland, 20852-9787; or on the MedWatch website at wwww.fda.gov/Safety/MedWatch/default.htm.