Healthy People cites unapproved use of sibutramine and tadalafil in supplements recall

Feb. 6, 2012—Healthy People recalled its dietary supplements that are sold under the brand name Healthy People because the products contain sibutramine and tadalafil, which makes them unapproved new drugs, according to Food and Drug Administration.

The following products and lot numbers are affected: Everlax Dietary Supplement HPCEX074, HPCEX076 and HPCEX072 that have UPC 7503013203046; Ever Slim Dietary Supplement HPCES079, HPCES070 and HPCES071 that have UPC 7503013203053; Ever Slim Shake Mix Dietary Supplement Chocolate HPESSC061 that has UPC 7503013203077; Ever Slim Shake Mix Dietary Supplement Strawberry HPESSF168 that has UPC 7503013203084; Herbal Drink Acai-man Mangosteen Dietary Supplement HPJAC004 that has UPC 7503013203015; Mince Belle Dietary Supplement HPCMB10026, HPCMB10027, HPCMB10029, HPCMB10020 and HPCMB10021 that have UPC 7503013203305; and Perfect Men Dietary Supplement HPCPM002 that has UPC 7503013203190.

Sibutramine is an FDA-approved drug for appetite suppressants in the treatment of obesity, making dietary supplements Everlax, Ever Slim, Ever Slim Shake Mix Dietary Supplement Chocolate, Ever Slim Shake Mix Dietary Supplement Strawberry and Mince Belle unapproved drugs. Sibutramine is a schedule IV controlled substance, and because of the risks that are associated with its use, it should be taken only under the direct supervision of a qualified health-care professional.

Sibutramine can increase blood pressure or pulse rates substantially in some patients and might present a significant risk to patients who have a history of arrhythmias, congestive heart failure, coronary artery disease or stroke. Sibutramine has been withdrawn from the U.S. consumer marketplace. The active drug ingredient isn’t listed on the label for the recalled products.

Tadalafil is an FDA-approved drug for the treatment of male erectile dysfunction (ED), making Herbal Drink Acai-man Mangosteen Dietary Supplement and Perfect Men Dietary Supplement unapproved drugs. Tadalafil might interact with nitrates that are found in prescription drugs such as nitroglycerin and might lower blood pressure to dangerous levels. Consumers who have diabetes, heart disease, high blood pressure or high cholesterol levels often take nitrates.

Consumers who have the affected lot numbers should return any unused product for a full refund to the company directly.

These products were sold at Healthy People store at 13105 Ramona Blvd., Irwindale, CA 91706, and can be returned or exchanged at the same location.

Customers may call 626/939-4132 Monday–Friday, 9:00 a.m.–5:00 p.m. PT for instructions about the return-and-refund process.