RockHard Weekend - product contains undeclared drug ingredient

Audience: Consumers, pharmacists

[Posted 11/18/2009] RockHard Laboratories and FDA notified consumers that RockHard Weekend, a product sold as a dietary supplement, contains sulfoaildenafil, an analogue of sildenafil, an FDA-approved drug used as treatment for Erectile Dysfunction. The presence of sulfoaildenafil makes RockHard Weekend an unapproved drug. This undeclared drug ingredient may interact with prescription drugs known as nitrates, including nitroglycerin, and cause dangerously low blood pressure.

RockHard Weekend is sold nationwide in single blisters, 3-count and 8-count bottles. The following lot numbers are affected by this recall:

• Blister Pack: T12 705 08 (exp: 10/11) / T12 705 09 (exp: 3/12, 8/12)
• 3ct Bottle: R417 0509 (exp: 09/12)
• 8ct Bottle: T237-0509 (exp: 06/12)

RockHard Laboratories advises any customers in possession of RockHard Weekend to return any unused product for a full refund to the company directly. Customers can call 1.800.562.0543 for instructions on the return and refund process.

The FDA advises consumers who have experienced any adverse events from sexual enhancement products to consult a health care professional. Any adverse events that may be related to use should be reported to the FDA's MedWatch Safety Information and Adverse Event Reporting Program online [at www.fda.gov/MedWatch/report.htm], by phone 1-800-332-1088, or by returning the postage-paid FDA form 3500 [which may be downloaded from the MedWatch "Download Forms" page] by mail [to address on the pre-addressed form] or fax [1-800-FDA-0178].

[11/09/2009 - Press Release - FDA]