- Company Announcement Date:
- FDA Publish Date:
- Product Type:
- Dietary Supplements
- Reason for Announcement:
Recall Reason DescriptionFDA analysis has found the product to contain Tadalafil
- Company Name:
- Organic Herbal Supply, Inc.
- Brand Name:
- Product Description:
Product DescriptionXtraHRD Natural Male Enhancement capsules
Organic Herbal Supply, Inc. announced today that it is conducting a voluntary nationwide recall of all lots of XtraHRD Natural Male Enhancement capsules. FDA analysis has found the product to contain Tadalafil. Tadalafil is a FDA-approved drug used as treatment for male Erectile Dysfunction (ED). The active drug ingredients are not listed on the label for this product. To date, no adverse events have been reported.
XtraHRD Natural Male Enhancement capsules are marketed as a dietary supplement for erectile dysfunction. It is packaged in 2, 4 and 10 count packages and sold nationwide.
Use of this product 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.
Organic Herbal Supply, advises any customers in possession of the XtraHRD 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.
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