Organic Herbal Supply Supplement Products: Recall - Undeclared Drug Ingredients
Audience: Consumer
Including Uproar, Cummor, Zrect, LabidaMAX, Monkey Business, Xrect, Rectalis, Tornado, Zdaily, BigNHard, Enhancerol Natural Male Enhancement capsules
ISSUE: Organic Herbal Supply, Inc. announced that it is conducting a voluntary nationwide recall of all lots of Uproar, Cummor, Zrect, Monkey Business, Xrect, Rectalis, Tornado, Zdaily, BigNHard, Enhancerol Natural Male Enhancement capsules. FDA analysis has found the products to contain Tadalafil. Tadalafil is a FDA-approved drug used as treatment for male Erectile Dysfunction (ED). The presence of tadalafil in these male enhancement products renders it an unapproved drug for which safety and efficacy have not been established. Organic Herbal Supply is also recalling Zrect for Women and LabidaMAX. FDA analysis has found these two products contain Flibanserin, an FDA-approved prescription drug for Hypoactive Sexual Desire Disorder (HSDD) in women. See the firm's press release for a listing of product UPC codes.
Use of these products may pose a threat to consumers because the undeclared active ingredients 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. ED is a common problem in men with these conditions, and consumers may seek these types of products to enhance sexual performance.
BACKGROUND: Uproar, Cummor, Zrect, Monkey Business, Xrect, Rectalis, Tornado, Zdaily, BigNHard, Enhancerol Natural Male Enhancement capsules are marketed as a dietary supplement for erectile dysfunction. They are packaged in 2, 4 and 10 count packages and sold nationwide. Zrect for women and LabidaMAX were packaged in 30 count packages and sold nationwide through Amazon.com and through Zrect.com. Organic Herbal began shipping this product on or around December 2014 through February 2017.
RECOMMENDATION: Organic Herbal Supply, advises any customers in possession of the Uproar, Cummor, Zrect, Monkey Business, Xrect, Rectalis, Tornado, Zdaily, BigNHard, Enhancerol, Zrect for Women, LabidaMAX to stop using and return any unused product for a full refund to the company directly. Customers can call 855-429-7328 between the hours of 10 a.m. and 5 p.m. Pacific Standard Time for instructions on the return and refund process. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this 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.accessdata.fda.gov/scripts/medwatch/index.cfm
- 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
[04/18/2017 - Press Release - Organic Herbal Supply]
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