X-Rock Recall: Undeclared Drug Ingredient Poses a Threat to Consumers

FDA informs consumers that certain supplement products with the brand name X-Rock are recalled by the company XRock Industries LLC because they contain undeclared active ingredients that pose a threat to consumers.

Background of XRock

X-Rock For Men, distributed by XRock Industries, is a sexual enhancement product, distributed Nationwide in single blister cards via internet orders and by telephone.

X-Rock For Men

FDA Alert on X-Rock

FDA conducted analytical tests of X-ROCK for Men leading to the conclusion that these products contained the undeclared ingredients Sildenafil and Hydroxythiohomosildenafil. Hydroxythiohomosildenafil’s structure is close to that of Sildenafil and it is expected to have similar adverse events.

Both undeclared ingredients pose a threat to consumers because by interacting with nitrates they lower blood pressure to dangerous levels. Nitrates can be found in prescription drugs for consumers with heart disease, high cholesterol, high blood pressure and diabetes. Men with these conditions might have Erectile Dysfunction problem seeking products in order to enhance their sexual performance. Other side effects are flushing and headaches.

All codes of X-Rock for Men, within expiration, are included in this recall.

X-Rock For Men

Recommendation on X-Rock

“Customers who have this product in their possession should stop using it immediately and contact their physician if they have experienced any problems that may be related to taking this product. The Company is advising consumers to return any unused X-Rock to the retail location from which it was purchased or to the Company directly if it was purchased from the Company as a part of its Direct Response Program.”

Contacting the FDA to report cases with X-Rock

In case of detection of adverse events or side effects related to the use of X-Rock, healthcare professionals and patients should report it to the FDA’s MedWatch Safety Information and Adverse Event Reporting program through any of the following ways:

The report can be completed and submitted Online at: www.fda.gov/MedWatch/report.htm

The form can be downloaded or requested by calling 1-800-332-1088, then completed and returned on the address indicated on the form

The completed form can be faxed to:  1-800-FDA-0178

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