RockHard Weekend ED dietary supplement: unapproved drug

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FDA recall:

Recall -- Firm Press Release

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RockHard Laboratories Issues a Voluntary Nationwide Recall of Specific Lots of RockHard Weekend Marketed as Dietary Supplement

Contact:
RockHard Laboratories,
800-562-0543
customerservice@rockhardweekend.com

FOR IMMEDIATE RELEASE - November 9, 2009 - Atlanta, GA – RockHard Laboratories announced today that it is conducting a voluntary nationwide recall of the company’s dietary supplement sold under the name RockHard Weekend (RHW) specific to the following Lot Numbers:
Blister Pack: T12 705 08 (exp: 10/11) / T12 705 09 (exp: 3/12, 8/12)
3ct Bottle: R417 0509 (exp: 09/12)
8ct Bottle: T237-0509 (exp: 06/12)
RockHard Laboratories is conducting a voluntary recall after being informed by the Food and Drug Administration (FDA) that voluntary lab analysis found that RHW, specific to the above lot numbers, contains sulfoaildenfil, an analogue of Sildenfil, an FDA-approved drug used as treatment for male E rectile Dysfunction (ED) making RockHard Weekend an unapproved drug. The active drug ingredient is not listed on the product label.
The undeclared ingredient may pose a threat to consumers because the analogue 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 ***ual performance.
RockHard Laboratories takes the upmost pride in its quality control by outsourcing production to a certified, independent lab. It is through this outside lab that RockHard Laboratories maintains the highest quality standards possible and can quickly take action. RockHard Laboratories has identified that one of the lab’s raw ingredients, sourced from China, was being unknowingly tainted with sulfoaildenfil. RockHard Laboratories takes this recall very seriously and recommits to the diligent work required in ensuring its products remain free of any potentially unapproved chemicals.
RHW is sold nationwide in single blisters, 3-count and 8-count bottles. RockHard Laboratories advises any customers in possession of RHW to return any unused product for a full refund to the company directly. Customers can call 1.800.562.0543 for instructions on the return and refund process.
RockHard Laboratories is committed to improving its product and avoiding future recall issues by sourcing higher quality raw ingredients and expanding testing. RockHard Laboratories promises its customer the highest possible quality and welcomes the recall process as further evidence of our commitment to our brand, products and consumers.
Any adverse events that may be related to the use of this product should be reported to the FDA's MedWatch Adverse Event Reporting program online [at www.fda.gov/MedWatch/report.htm], by returning the postage-paid FDA form 3500 [which may be downloaded from www.fda.gov/MedWatch/getforms.htm] by mail [to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787] or fax [1-800-FDA-0178].