X-Rock and Z-Rock Male Supplement products have been recalled for an undeclared drug ingredient, the U.S. Food & Drug Administration (FDA) just announced. The supplements are manufactured by CRM Laboratories, which is conducting a consumer/user level recall of all of its X-ROCK 3-Day Pill For Men and Z-ROCK products sold between October 2011 and April, 2012.
The X-ROCK 3-Day Pill for Men and Z-ROCK products were tested and found to contain an analogue of an ingredient in an FDA-approved drug. Analytical tests conducted by the FDA concluded that the products contained sildenafil and hydroxythiohomosildenafil.
Hydroxythiohomosildenafil is an analogue of sildenafil, is close in structure to sildenafil, and is expected to possess a similar pharmacological and adverse event profile. Sildenafil is the active pharmaceutical ingredient in an FDA-approved drug used to treat erectile dysfunction (ED), making these products unapproved new drugs.
These undeclared active ingredients pose a threat to consumers because sildenafil and hydroxythiohomosildenafil may interact with nitrates found in some prescription drugs, such as nitroglycerin, and can 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 they may seek products to enhance sexual performance. Also, hydroxythiohomosildenafil, like sildenafil, may cause side effects, such as headaches and flushing.
All codes of X-Rock 3-Day Pill for Men and Z-Rock All Natural Male Supplement, within expiration, are included in this recall.
The supplements are individually packaged blue capsules delivered on a cardboard blister card; older packaging configurations may include blister double packs (2 capsules per blister card) and white plastic bottles (6-, 12-, and 24-count). The products were sold, wholesale, to U.S. distributors who further distributed the supplements, nationwide, through Internet sales and at retail.
The back panel on the X-Rock 3-Day Pill for Men may read “Distributed by XRock Industries PO Box 120863 Ft. Lauderdale, FL 33312” or “MATE Enterprises 1020 N. Venetian Drive Miami, Florida 33139 www.XRockHim.com (888) XROCK-HIM).” The Z-Rock All Natural Male Supplement back panel will read “Distributed By XRock Industries PO Box 120863 Ft. Lauderdale, FL 33312 www.ZrockUSA.com 877-976-2563.”
XROCK Industries states that, to date, it has not received any reports of adverse events related to this recall.
Customers who have these products in their possession should stop using them immediately and contact their physician if they have experienced any problems that may be related to taking this product. The company also advises consumers to return any unused products, for a refund of the full purchase price, to the retail location from which it was purchased or to the company directly. The company can be reached at 1.305.587.9830, Monday through Friday, from 9:00 a.m. to 5:00 p.m., Eastern Standard Time (EST), to receive instructions for returning the products.
Adverse events or quality problems experienced with this product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail, or by fax: Online, go to http://www.fda.gov/medwatch/report.htm; by regular mail, use postage-paid, pre-addressed Form FDA 3500 available at http://www.fda.gov/MedWatch/getforms.htm and mail to the address on the preaddressed form; or fax to 1.800.FDA.0178.