Recall -- Firm Press Release

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Healthy People Co. Issues a Voluntary Recall of Specific Lots of the Dietary Supplements Found to Contain Undeclared Drug Ingredients

Contact:
Consumer:
Healthy People Co. Customer Service Department
626-939-4132

FOR IMMEDIATE RELEASE - February 3, 2012 - Healthy People Co. announced today that it is conducting a voluntary nationwide recall of the company’s dietary supplements sold under the brand names Healthy People Co. specific to the following Lot Numbers:

Healthy People Co. is conducting a voluntary recall because FDA lab analysis has confirmed the presence of Sibutramine and Tadalafil, making these products unapproved new drugs.

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 Sibutramine has been withdrawn from the U.S. marketplace.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 Herbal Drink Acai-man Mangosteen 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. Healthy People Co. advises any customers in possession of the products listed above with matching the lot numbers to return any unused product for a full refund to the company directly. Customers can call 626-939-4132 M-F 9am-5pm (PST) for instructions on the return and refund process.

These products were sold, or distributed at our store located at: 13105 Ramona Blvd Ste F, Irwindale, CA, 91706, and can be returned, and exchanged at the same location.

Healthy People Co. is committed to improving its products and avoiding future recall issues by sourcing higher quality raw ingredients and expanding testing. Healthy People Co. promises its customers the highest possible quality and welcomes the recall process as further evidence of our commitment to our brands, products and consumers.

Any adverse reactions or quality problems experienced with the use of these products may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Online: http://www.fda.gov/MedWatch/report.htm⁹
• Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: http://www.fda.gov/MedWatch/getforms.htm¹⁰. Mail to address on the pre-addressed form.
• Fax: 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
 

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Link to expanded press release with corrections