Organic Herbal Supply Issues Voluntary Nationwide Recall Of All Lots Of Various Supplements For Male And Female Sexual Enhancement Due To Undeclared Active Ingredients

COMPANY ANNOUNCEMENT

Summary

• Company Announcement Date: April 18, 2017
• FDA Publish Date: February 08, 2018
• Product Type: Drugs
• Reason for Announcement: Undeclared Active Ingredients tadalafil, sildenafil and analogues
• Company Name: Organic Herbal Supply, Inc.
• Brand Name: Uproar, Cummor, Zrect, Monkey Business and others
• Product Description: Dietary Supplement

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Company Announcement

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, sildenafil and their analogues.  These are FDA-approved prescription drugs used as a treatment for male Erectile Dysfunction (ED).  Organic Herbal Supply is also recalling Zrect for Women and LabidaMAX capsules.  FDA analysis has found these two products to contain Flibanserin, a FDA-approved prescription drug for Hypoactive Sexual Desire Disorder (HSDD) in women).  The presence of the undeclared active ingredients renders them unapproved drugs for which safety and efficacy have not been established.
 
Use of products with undeclared tadalafil, sildenafil and their analogues may pose a threat to consumers because the active ingredient 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.  Additionally, use of products with undeclared flibanserin, could result in dizziness, somnolence, nausea, fatigue, insomnia and dry mouth which are common side effects.  However, more significant health consequences such as excessive sedation and somnolence, significant hypotension leading to syncope particularly dangerous in individuals with major cardiovascular morbidities which could be life-threatening may occur if taken with concomitant use of alcohol, CNS depressants or medications that could increase flibanserin concentration.

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.  Zrect for women and LabidaMAX are marketed as a dietary supplement for women with low sexual desire.  They are packaged in 30 count blister packs.  All products are sold nationwide through Amazon.com and through Zrect.com.  Organic Herbal began shipping these products on or around December 2014 through February 2017.
  
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.

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

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.

Uproar  UPC #680474229260, Cummor UPC#680474229116, Zrect UPC #852675999451, Monkey Business UPC#688295456179, Xrect UPC#680474015795, Recatlis UPC#680474228782, Tornado UPC #680474228959, Z Daily UPC #680474229086, Enhancerol UPC#680474229086, Zrect for Women UPC #680474229055, LabidaMAX UPC #680474228904
 

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Consumers

Organic Herbal Supply
 855-429-7328