Vegetable Vigra by Natures Supplement: Recall - Undeclared Drug Ingredient
Audience: Consumer
[Posted 09/21/2017]
ISSUE: Natures Supplement, Inc. is voluntarily recalling 260 bottles of Vegetable Vigra, 200 mg capsules to the consumer level. FDA analysis found this product to be tainted with Sidenafil. Sildenafil is an FDA approved drug for the treatment of erectile dysfunction. The presence of Sildenafil in the Vegetable Vigra product renders it an unapproved drug for which safety and efficacy has not been established, therefore subject to recall.
Men with diabetes, high blood pressure, high cholesterol, or heart disease, may be on medications that, taken with this product, could lower blood pressure to dangerous levels that could be life-threatening.
BACKGROUND: The product is used as a natural male enhancement and packaged in a bottle with green label. The affected Vegetable Vigra includes all lots remaining within expiry. The product can be identified by label “enhanced Vegetable Vigra". Product was distributed in Florida to consumers via 3rd party distribution company.
RECOMMENDATION: Natures Supplement Inc is notifying its distributor by mail and is arranging for return of all recalled products. Distributors and consumers that have product which is being recalled should stop selling/using the product and return to point of purchase.
Consumers with questions regarding this recall can contact Natures Supplement by phone 561-281-7212 Monday thru Friday 9am to 5pm Eastern Standard Time or naturessupplement@yahoo.com Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug 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
[09/20/2017 - Press Release - Natures Supplement, Inc]
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