October 30, 2014

US Marshals Seize Dietary Supplements from Globe All Wellness LLC

FPBantibioticsU.S. Marshalls, acting on behalf of the FDA, seized tainted dietary supplements from Globe All Wellness LLC in Hollywood, Florida. The products contain an undisclosed active pharmaceutical ingredient.

The products allegedly contain sibutramine hydrochloride (sibutramine), which is the active ingredient in the obesity drug Meridia. Meridia was withdrawn from the market in December 2010 after clinical data showed it increased the risk of heart attack and stroke. Howard Sklamberg, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research said, “companies that distribute products containing undisclosed drugs are not only breaking the law, they are putting consumers at risk. With these kinds of hidden dangers, ¬†consumers cannot make informed decisions about the products they are taking.”

Marshals seized various lots of these products: SlimXtreme, SlimXtreme Gold, SlimPlus, SlimLee, GelSlim, SlimDrops, and Colonew. The company received a warning letter¬†from the FDA on February 6, 2012 telling them their products contained an unapproved drug. No illnesses have been reported to date that are associated with Globe All’s products. Any illnesses should be reported to the FDA by calling 1-800-FDA-1088.

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