Organic Herbal Supply Issue Voluntary Nationwide Recall Of All Lots Of Various Supplements For Male And Female Sexual Enhancement Due To Undeclared Tadalafil And Flibanserin

You are subscribed to Recalls, Market Withdrawals and Safety Alerts for U.S. Food & Drug Administration (FDA).

This information has recently been updated and is now available.

 

 

Organic Herbal Supply Issue Voluntary Nationwide Recall Of All Lots Of Various Supplements For Male And Female Sexual Enhancement Due To Undeclared Tadalafil And Flibanserin

04/18/2017 08:25 PM EDT

Organic Herbal Supply, Inc. announced today 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 and, therefore, subject to recall. 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. There have been no reports of illness to date.

For detailed information pertaining to this Recalls, Market Withdrawals and Safety Alerts message, please click the link at the beginning of this bulletin.

---

Manage your FDA Subscriptions:

• Update your preferences or unsubscribe
• Questions about this service? Please visit subscriberhelp.govdelivery.com
• Other inquiries? webmail@oc.fda.gov

---

This email was sent to filter@clubhouseb.com using GovDelivery, on behalf of: U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring, MD 20993 · 1-888-INFO-FDA (1-888-463-6332)