Recalls

Step 2 dietary supplements recalled, contain dangerous, undeclared ingredients

supplements 249x210 Step 2 dietary supplements recalled, contain dangerous, undeclared ingredientsBody Shot Bar is recalling all lots of its Step 2 60 gold capsule dietary supplements because they contain undeclared and unapproved drugs that put consumers at serious health risk.

An FDA sampling and testing found that Step 2 tested positive for sibtramine, an appetite suppressant that was pulled form the market by the Food and Drug Administration (FDA) due to serious health risks. The now-illegal drug ingredient is known to substantially increase blood pressure and/or pulse rate. People with a history of coronary artery disease, congestive heart failure, arrhythmia or stroke may be at significant risk. The drug has been linked to heart attacks and cardiac arrest.

Step 2 was also found to contain phenolphthalein, an ingredient previously used in over-the-counter laxatives, but because of concerns of carcinogenicity it is not currently approved for marketing in the U.S. Health risks associated with phenolphthalein include 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,” the FDA said in a Safety Announcement. “These products may also interact in life-threatening ways with other medications a consumer may be taking.”

Affected Step 2 dietary supplements are packaged in a white bottle in blue and gold, and include the expiration date 7/30/2017. The products were distributed throughout the U.S. via www.thebodyshotbar.com from March 1, 2016, through May 6, 2016.

No adverse events have been reported to date. Side effects experienced by anyone who has consumed these products should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.

Source: FDA