Public Health Officials remind consumers to talk to their healthcare provider before taking any dietary supplements
CRM Laboratories has recalled of all X-ROCK 3 Day Pill For Men and Z-ROCK products sold between October, 2011 and April, 2012. Analytical tests conducted by the Food and Drug Administration (FDA) concluded that the products contained sildenafil and hydroxythiohomosildenafil. Hydroxythiohomosildenafil is an analogue of sildenafil and 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 a FDA approved drug that is 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 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. Additionally, 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 products are blue capsules individually packaged on a cardboard blister card; some older packaging configurations include blister double pack (2 capsules per blister card) and white plastic bottles (6, 12, 24 count). The products were sold as wholesale in the US to distributors who further distributed it nationwide through internet sales and at retail.
- X-Rock 3 Day Pill for Men back panel 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).
- 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.
The Company 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 is advising 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. Consumers can call 305-587-9830 Monday through Friday 6am-2pm PST to receive instructions for returning the products.
The FDA and the Monterey County Health Department also encourage consumers to consult with their health care professional before taking any dietary supplements.
All consumers should be aware of the following signs of health fraud:
- Promises of an "easy" fix for problems like excess weight, hair loss, or impotency.
- Claims such as "scientific breakthrough," "miraculous cure," "secret ingredient," and "ancient remedy."
- Impressive-sounding terms, such as "hunger stimulation point" and "thermogenesis" for a weight loss product.
- Claims that the product is safe because it is "natural."
- Undocumented case histories or personal testimonials by consumers or doctors claiming amazing results.
- Promises of no-risk, money-back guarantees.
- Claims that the product is a replacement for a prescription medication
Any adverse events that may be related to the use of the affected products should be reported to the FDA's MedWatch Adverse Event Reporting program. The report may be made by phone at 1-800-FDA-1088, online at www.fda.gov/MedWatch/report.htm, or by returning the postage paid FDA form 3500. The form may be downloaded from www.fda.gov/MedWatch/getforms.htm and mailed to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787 or faxed to 1-800-FDA- 0178.
The Monterey County Health Department releases notices of recalls and market withdrawal from the firms involved as a service to Monterey County residents, the media and other interested parties. The Health Department does not endorse either the product or the company.