Body Basics Inc. just issued a recall of dietary supplements because they were manufactured with a dangerous drug ingredient, the U.S. Food & Drug Administration (FDA) announced.
The supplement manufacturer issued a nationwide recall of its ACTRA-Sx 500 Dietary Supplement Capsules, Lot 008-A, Expiration December 2013. ACTRA-Sx 500, is a purple and gold capsule sold in five-count bottles with UPC 830733002015.
Body Basics, through independent lab analysis, confirmed the presence of Sildenafil Citrate, which is not listed on the label for the recalled ACTRA-Sx 500 dietary supplement. The presence of this component makes the ACTRA-Sx 500 an unapproved new drugs. Sildenafil is the active ingredient used in an FDA-approved drug to treat erectile dysfunction (ED).
The agency warns that use of this product may pose a threat to consumers because it may interact with nitrates found in some prescription drugs, such as nitroglycerin. The supplement may also lower blood pressure to dangerous levels. Of note, consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates and ED is a common problem in men with these conditions; consumers may seek these types of products to enhance sexual performance.
Body Basics Inc. distributed ACTRA-Sx 500 via sales made to independent distributors in the Los Angeles, California area, as well as directly to some consumers. Body Basics Inc. does not distribute or sell ACTRA-Sx 500 on the Internet.
Body Basics Inc. is warning distributors and consumers who purchased this product not to distribute, sell, or consume the recalled supplement. Body Basics ceased distribution of the recalled ACTRA Sx-500 November 2011; however, consumers may still be in possession of the recalled product and are warned to stop its use immediately. The firm advises customers in possession of the recalled ACTRA-Sx 500 to return any unused product to the company for a full refund.
The firm also noted that, since there is no practical or economical way to determine if the product purchased is contaminated, consumers are encouraged to contact Body Basics Inc., toll-free, at 1.800.595.2718 for instructions, a return policy, and any questions or concerns. The company said it is unaware of any complications or health problems.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax: Online at www.fda.gov/medwatch/report.htm or by regular mail or fax by using postage-paid, pre-addressed Form FDA 3500 available at www.fda.gov/MedWatch/getforms.htm and mail to address on the pre-addressed form or fax to 1.800.FDA.0178.