X-Rock for Men Dietary Supplement Recall
|Date:||April 19, 2012|
|What:||X-Rock for Men Dietary Supplement|
|Why:||Contains a prescription drug|
Xrock Industries of Fort Lauderdale, Florida is recalling X-Rock for Men because analytical tests conducted by the U.S. Food and Drug Administration (FDA) concluded that it contains sildenafil and hydroxythiohomosildenafil. Hydroxythiohomosildenafil is an analogue of sildenafil, the active pharmaceutical ingredient in an FDA approved drug that is used to treat erectile dysfunction (ED).
Hydroxythiohomosildenafil is close in structure to sildenafil and is expected to possess a similar pharmacological and adverse event profile. 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. Erectile dysfunction 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 for Men packaged as one capsule blister card sold individually, UPC 0030950792, and all lots numbers within expiration, are subject to this recall.
Xrock Industries has not received any reports of adverse events related to this recall.
XRock for Men was distributed in single blister cards nationwide to wholesalers and retail to the consumer via internet orders and by telephone.
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 for a refund of the full purchase price, to the retail location from which it was purchased. Consumers can call 1-877-976-2563, Monday through Saturday from 9 a.m. - 9 p.m. Eastern time to receive instructions for returning the product.
Any adverse events or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program by:
- Online: www.fda.gov/medwatch/report.htm
- Fax: 800-FDA-0178
- Phone: 800-FDA-1088
- Regular Mail: use postage-paid FDA form 3500 available at www.fda.gov/MedWatch/getforms.htm and mail to:
5600 Fishers Lane
Rockville, MD 20852-9787
Consumers with questions about food safety can Ask Heidi, a certified food safety professional.