RECALL: Actra-Sx 500 Contains Undeclared Ingredient
Body Basics Inc. is conducting a voluntary nationwide recall of Actra-Sx 500 dietary supplement capsules after confirming the presence of sildenafil citrate, making this product an unapproved new drug. Sildenafil citrate is the active ingredient used in Viagra (Pfizer) to treat erectile dysfunction (ED).
Use of this product may pose a threat to consumers because it may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels.
The affected lot # is 008-A with an expiration date of December 2013 supplied in a 5-count bottle. Body Basics Inc. is warning distributors and consumers who purchased this product not to distribute, sell or consume this product. Although distribution ceased in November 2011, consumers are to cease all use of this product if they are still holding the affected lot number and expiration date.
For more information visit http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm319765.htm.