RockHard Laboratories is conducting a voluntary nationwide recall of specific lots of its dietary supplement sold under the name RockHard Weekend (RHW), the U.S. Food & Drug Administration (FDA) just announced.
RockHard Laboratories is conducting the recall after being informed by the FDA that voluntary lab analysis found that RHW, specific to the affected lot numbers, contains sulfoaildenfil, an analogue of Sildenfil, an FDA-approved drug used as treatment for male Erectile Dysfunction (ED). This makes RockHard Weekend an unapproved drug. The active drug ingredient is not listed on the product label.
The lot numbers involved in the recall are:
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)
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 sexual performance.
According to the FDA, RockHard Laboratories has identified that one of its lab’s raw ingredients, sourced from China, was being unknowingly tainted with sulfoaildenfil.
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.
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 by fax [1-800-FDA-0178].
Of note, defective imports from China have been making headlines in recent years; the Rockhard Weekend Dietary Supplement recall is another of many such issues on which we have been writing. In 2008, nearly 80 percent of all product recalls in the United States involved imports from China. Products such as dog food, baby formula, toys with lead paint, and even pharmaceuticals like heparin have been found to have been made with toxic materials and other counterfeit ingredients that have long been putting United States consumers at significant risk. Also making news is the ongoing Chinese drywall disaster involving imports from that country.
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