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Two Dietary Supplement Products Recalled Due to Presence of Sildenafil
Manufacturer CRM Laboratories has initiated a voluntary recall of two products marketed as dietary supplements to support male sexual performance due to the presence of sildenafil and hydroxythiohomosildenafil. The products, X-ROCK 3 Day Pill For Men and Z-ROCK, were distributed through wholesalers nationwide and made available to consumers on the Internet and in retail settings. As indicated in a press release on the FDA Web site, sildenafil is the active pharmaceutical ingredient in an FDA-approved drug that is used to treat erectile dysfunction, 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. Customers who have these products in their possession should stop using them immediately and contact their health care provider if they have experienced any problems that may be related to taking this product. Instructions for returning the products are included in the press release. FDA reminds consumers that any adverse events or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting Program by calling 800/332-0178 or by completing the online form.
