ACTRA-Sx 500 Capsules Recalled due to Undeclared Ingredient Sildenafil Citrate

The FDA informs healthcare professionals and consumers that ACTRA-Sx 500 Capsules are recalled because they contain an undeclared ingredient, Sildenafil Citrate, and the drug is unapproved posing a threat to consumers.

Background of ACTRA-Sx 500 Capsules

ACTRA-Sx 500 Capsules, by Body Basics Inc., are sold as dietary supplement. They are purple and gold capsule in bottles of 5 count.

The UPC code is 830733002015.

FDA Alert on ACTRA-Sx 500 Capsules

Independent lab analysis revealed that ACTRA-Sx 500 Capsules contain the undeclared ingredient, Sildenafil Citrate, which is the active ingredient in another FDA approved drug for the treatment of erectile dysfunction. Therefore, ACTRA-Sx 500 is an unapproved drug.

Moreover, this drug may interact with nitrates, often present in drugs for heart disease, high cholesterol and diabetes, lowering blood pressure to dangerous levels.

Recommendation on ACTRA-Sx 500 Capsules

“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.”

Contacting the FDA to report cases with ACTRA-Sx 500 Capsules

In case of detection of adverse events or side effects related to the use of ACTRA-Sx 500 Capsules, healthcare professionals and patients should report it to the FDA’s MedWatch Safety Information and Adverse Event Reporting program through any of the following ways:

The report can be completed and submitted online at: www.fda.gov/MedWatch/report.htm

The form can be downloaded or requested by calling 1-800-332-1088, then completed and returned on the address indicated on the form

The completed form can be faxed to: 1-800-FDA-0178

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