A recall of dietary supplements has been issued over potential contamination with drug ingredients, the U.S. Food and Drug Administration (FDA) just announced.
Healthy People Co. said it is recalling its dietary supplements sold under the brand Healthy People Co. and that the recall involves the following items:
30 Capsule Dietary Supplements
- • Mince Belle: Lots HPCMB/10-026, HPCMB/10-027, HPCMB/10-029, HPCMB/10-020, HPCMB/10-021; UPC7503013203305.
- • Perfect Men: Lot HPCPM/002; UPC7503013203190.
- • Everlax: Lots HPCEX/074, HPCEX/076, HPCEX/072; UPC 7503013203046.
- • Ever Slim: Lots HPCES-079, HPCES-070, HPCES-071; UPC 7503013203053.
16.6 Fluid Ounce Dietary Supplement
- • Herbal Drink Acai-Man Mangosteen: Lot HPJAC/004; UPC7503013203015.
17.6 Fluid Ounce Dietary Supplement
- • Ever Slim Shake Mix Strawberry: Lot HPESSF/168; UPC7503013203084.
- • Ever Slim Shake Mix Chocolate: Lot HPESSC/061; UPC7503013203077.
FDA lab analysis confirmed the presence of Sibutramine and Tadalafil in these products, which makes them unapproved new drugs.
Sibutramine is an FDA-approved appetite suppressant drug that treats obesity. Because of this, the following dietary supplements are considered unapproved drugs: Mince Belle, Everlax, Ever Slim, Ever Slim Shake Mix Dietary Supplement Strawberry, and Ever Slim Shake Mix Dietary Supplement Chocolate. Sibutramine, a Schedule IV controlled substance, should be taken only under the direct supervision of a qualified health care professional. Sibutramine, which has been withdrawn from the U.S. marketplace, is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk to patients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. The active drug ingredient is not listed on the label for these recalled products.
Tadalafil is a FDA approved for the treatment of male Erectile Dysfunction (ED), which makes Perfect Men Dietary Supplement and Herbal Drink Acai-Man Mangosteen Dietary Supplement unapproved drugs. The FDA advises that these products post 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. People with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Healthy People Co. advises any customers in possession of these recalled products to return any unused product for a full refund to the company directly. Customers can call 1.626.939.4132, Monday through Friday, from 9:00 a.m. to 5:00 p.m. Pacific Standard Time (PST) for instructions on the return and refund process.
The recalled products were sold or distributed at the Healthy People store located at 13105 Ramona Blvd Ste F, Irwindale, California, 91706. Products can be returned and exchanged at this location.