  |
ACTRA-Sx 500 Capsules by Body Basics Inc.: Recall - Undeclared Drug Ingredient
AUDIENCE: Consumer, Health Professional
ISSUE: Body Basics Inc. announced that it is conducting a voluntary nationwide recall of ACTRA-Sx 500 Dietary Supplement Capsules, Lot 008-A, Expiration December 2013. The Company, through independent lab analysis, has confirmed the presence of Sildenafil Citrate, the active ingredient used in an FDA approved drug to treat Erectile Dysfunction (ED), making this product an unapproved new drug. 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.
BACKGROUND: Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Because erectile dysfunction is a common problem in men with these conditions, consumers may seek these types of products to enhance sexual performance. ACTRA-Sx 500, is a purple and gold capsule sold in bottles of 5 count with a UPC code of 830733002015.
RECOMMENDATION: Body Basics Inc. is warning distributors and consumers who purchased this product not to distribute, sell or consume this product. Although Body Basics voluntarily ceased distribution of this product in November 2011, if consumers are still holding this product bearing that lot number and expiration date, consumers are to cease all use of this product immediately. Any customer in possession of the ACTRA-Sx 500 product is advised to return any unused product for a full refund to the Company directly.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Read the MedWatch safety alert, including a link to the Press Release, at:
You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm
Update your subscriptions, modify your e-mail address, or stop subscriptions at any time on your Subscriber Preferences Page. You will need to use your e-mail address to log in. If you have questions or problems with the subscription service, please contact support@xxxxxxxxxxxxxxx.
This service is provided to you at no charge by U.S. Food & Drug Administration (FDA).
| This email was sent to list-fda@xxxxxxxxxxx using GovDelivery, on behalf of: U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring, MD 20993 · 800-439-1420 |  |
