X-ROCK INDUSTRIES, an independent distributor of X-Rock products, is recalling some of its X-Rock Male Supplements, the U.S. Food & Drug Administration (FDA) announced.
The finished product of X-Rock for Men—sold by XROCK INDUSTRIES and under the brand name X-Rock—was tested and found to contain an analogue of an ingredient in an FDA-approved drug. Analytical tests conducted on X-Rock for Men by the FDA revealed that the recalled X-Rock for Men products contained sildenafil and hydroxythiohomosildenafil.
Hydroxythiohomosildenafil is an analogue of sildenafil, which is the active pharmaceutical ingredient in an FDA-approved drug used to treat erectile dysfunction (ED). Hydroxythiohomosildenafil is similar in structure to sildenafil and is expected to possess a similar pharmacological and adverse event profile.
These ingredients present a threat to consumers because they may interact with nitrates, which can be found in some prescription drugs, such as nitroglycerin, and might also lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates and ED is a common problem in men with these conditions. These men may seek products to enhance sexual performance.
Hydroxythiohomosildenafil and sildenafil, may also cause other side effects, including headaches and flushing.
All codes of X-Rock for Men, within expiration, are included in this recall. The recalled product bears UPC 0030950792 and is sold individually in a one-capsule blister card. All lot numbers are involved.
X-Rock for Men was distributed nationwide to wholesalers and at the retail level to the consumer by telephone and through Internet orders from www.XRockMe.com, www.XRockHim.com, and www.XRockFlorida.com. To date, XROCK INDUSTRIES has not received any reports of adverse events related to this recall.
Customers in possession of the recalled X-Rock for Men product should stop using it immediately and contact their physician if they have experienced any problems that may be related to taking this recalled product. Customers are also advised to return any unused and recalled X-Rock for Men for a refund of the full purchase price, to the retail location from which it was purchased or to the XROCK INDUSTRIES, if purchased from XROCK INDUSTRIES as a part of its Direct Response Program. The firm can be reached, by telephone, toll-free, at 1.877.976.2563, Monday through Saturday, 9:00 a.m. to 9:00 p.m., Eastern Standard Time (EST), for return instructions. Additional information can also be found on the firm’s web site at www.XROCKME.com.
Adverse events or quality problems may be reported to the FDA’s MedWatch Adverse Event Reporting Program online, by regular mail or by fax: Online: http://www.fda.gov/medwatch/report.htm; regular mail using the postage-paid, pre-addressed Form FDA 3500 available at: http://www.fda.gov/MedWatch/getforms.htm and mailing to the address on the form; or by Fax: 1-800-FDA-0178.