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.
Risk Statement: Men with diabetes, high blood pressure, high cholesterol, or heart disease, may be on medications that taken with these products could lower blood pressure to dangerous levels that could be life-threatening. To date, Natures Supplement, Inc. has not received any reports of adverse events related to this recall.
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 xpiry. The product can be identified by label “enhanced Vegetable Vigra. Product was distributed in Florida to consumers via 3rd party distribution company.
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.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
• Complete and submit the report Online: www.fda.gov/medwatch/report.htm
• Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm 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
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
###
Leave a Reply