Step 2 60 Gold by The Body Shot Bar: Recall - Undeclared Drug Ingredients

[Posted 06/07/2016]

AUDIENCE: Consumer

ISSUE: The Body Shot Bar is voluntarily recalling all lots distributed March 1- May 6 2016 of Step 2 60 gold capsule (350MG per) capsules to the consumer level. Step 2 has been found positive for Sibutramine after FDA sampling and testing.

Sibutramine is an appetite suppressant that was withdrawn from the U.S. market in October 2010.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.

BACKGROUND: Step 2 60 Gold is marketed as a weight loss dietary supplement and is packaged in a white bottle in blue and gold. The affected Step 2 lots include the expiration date 7/30/2017. Product was distributed nationwide to consumers via www.thebodyshotbar.com

RECOMMENDATION: The Body Shot Bar is notifying its customers by Email and is arranging for return. Consumers that have recalled Step 2 should stop using and discard. Consumers with questions regarding this recall can contact The Body Shot Bar by phone (910)-849-3348 or thebodyshotbarinfo@yahoo.com on Monday thru Friday 10:00am to 5:30pm EST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report
• Download form 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

[06/07/2016 - Press Release - The Body Shot Bar]