Jersey Shore Supplements LLC, is recalling all lots of SlimFit X capsules because they contain dangerous hidden drug ingredients. The recall comes seven months after the FDA urged consumers not to use or purchase the diet pills because they contained illicit ingredients.
Laboratory analysis of SlimFit X capsules determined that the dietary supplements contained sibutramine and desmethylsibutramine. Sibutramine is a controlled substance that was removed from the market in October 2010 because it can increase blood pressure and heart rate in some patients and may pose a significant risk to patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke. Sibutramine may also interact in life-threatening ways with other medications. Desmethylsibutramine is a substance structurally similar to sibutramine and poses the same health risks to users.
The recall has been classified by the Food and Drug Administration (FDA) as a Class 1, the most serious type of recall which is reserved for products in which there is a reasonable probability that use will cause serious adverse health consequences or death.
The recall is part of the FDA’s efforts to crack down on a growing trend of dietary supplements or conventional foods manufactured with hidden drugs and chemicals. These products are typically promoted as “all natural” treatments for sexual enhancement, weight loss, or bodybuilding. The FDA says it is unable to test all products marketed as dietary supplements that have potentially harmful hidden ingredients.
“Consumers should exercise caution before purchasing any product in the above categories,” the FDA advised.
Any adverse event related to SlimFit X capsules should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.