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The FDA and RockHard Laboratories have notified consumers of a nationwide, voluntary recall of the dietary supplement RockHard Weekend. FDA lab analyses found the product to contain undeclared sulfoaildenfil, an analog of sildenafil, an FDA-approved drug for the treatment of erectile dysfunction. The presence of sulfoaildenafil makes RockHard Weekend an unapproved drug. Sulfoaidenafil may interact with nitrates found in some prescription drugs (eg, nitroglycerin) and may lower blood pressure to dangerous levels. Patients with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.
The following package sizes and lots of RockHard Weekend are being recalled:
- Blister Pack: Lot T12 705 08 (exp: 10/11), Lot T12 705 09 (exp: 3/12, 8/12)
- 3ct Bottle: Lot R417 0509 (exp: 09/12)
- 8ct Bottle: Lot T237-0509 (exp: 06/12)
Consumers who have this product in their possession should stop using it immediately and contact their healthcare professional if they experience any adverse events that may be related to the use of the product.
For more information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm191052.htm.
