February 23, 2012
Healthy People Co. Recalls Dietary Products Bought on or Before October 25, 2011
The Missouri Department of Health and Senior Services received the following recall regarding the expansion of Healthy People Co. dietary supplements to include all lot numbers sold on or before October 25, 2011. The original recall was initiated on Feb. 2, 2012.
FDA lab analysis confirmed the presence of Sibutramine and Tadalafil in the products identified herein, making the following products unapproved new drugs:
MINCE BELLE (Dietary Supplement, 30 Capsules)
LOT: HPCMB/10-026, HPCMB/10-027, HPCMB/10-029, HPCMB/10-020, HPCMB/10-021, HPCMB/10-016; UPC7503013203305
EVERLAX (Dietary Supplement, 30 Capsules)
LOT: HPCEX/074, HPCEX/076, HPCEX/072, HPCEX/032; UPC7503013203046
EVER SLIM (Dietary Supplement, 30 Capsules)
LOT: HPCES-079, HPCES-070, HPCES-071, HPCES/038; UPC7503013203053
EVER SLIM Shake Mix (Dietary Supplement Strawberry Contents17.6 oz.)
LOT: HPESSF/168: UPC7503013203084
EVER SLIM Shake Mix (Dietary Supplement Chocolate Contents17.6 oz.)
LOT: HPESSC/061: UPC7503013203077
ACAI-MAN MANGOSTEEN Herbal Drink (Dietary Supplement Contents 16.6 oz.)
LOT: HPJAC/004: UPC7503013203015
PERFECT MEN (Dietary Supplement, 10 Capsules)
LOT: HPCPM/002; UPC7503013203190
Sibutramine is an FDA-approved drug for appetite suppressant for the treatment of obesity, making dietary supplements: Mince Belle, Everlax, Ever Slim, Ever Slim Shake Mix Dietary Supplement Strawberry, and Ever Slim Shake Mix Dietary Supplement Chocolate unapproved drugs. It is a Schedule IV controlled substance and because of the risks associated with its use, it should be taken only under the direct supervision of a qualified health care professional. Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk to patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke. Sibutramine has been withdrawn from the U.S. marketplace. The active drug ingredient is not listed on the label for the products listed above.
Tadalafil is an FDA-approved drug for the treatment of male Erectile Dysfunction (ED), making Perfect Men Dietary Supplement and Acai-man Mangosteen Herbal Drink Dietary Supplement unapproved drugs. FDA advises that this poses a threat to consumers because Tadalafil may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.
These products were distributed nationwide.
The full recall announcement can be found at: http://www.fda.gov/Safety/Recalls/ucm292796.htm?source=govdelivery.