Table of contents
- Latest ACTRA-Sx Recall Updates
- October 12, 2018: Study Reviews Tainted Supplements Including ACTRA-Sx’s Drug
- September 12, 2012: Body Basics Recalls ACTRA-Sx 500 over Undeclared Drug
- Which ACTRA-Sx Are Affected?
- Why Was ACTRA-Sx Recalled?
- Reported Incidents, Injuries, or Illnesses
- What Should Consumers Do?
- Frequently Asked Questions
- Is the ACTRA-Sx Recall Still Active?
- What Are the Symptoms of a Sildenafil Interaction from ACTRA-Sx 500?
- Is the Sildenafil in ACTRA-Sx the Same Drug Used in Viagra?
- What Did the 2018 Study Find About Supplements Like ACTRA-Sx?
- How Do I Report a Problem with ACTRA-Sx to the FDA?
- Does the FDA Test All Dietary Supplements Like ACTRA-Sx Before They Reach Stores?
In September 2012, Body Basics Inc. pulled its ACTRA-Sx 500 dietary supplement from the market nationwide. Lab tests had turned up a hidden ingredient: sildenafil citrate, a prescription-only drug not shown anywhere on the label.
Sildenafil can interact with nitrate medications like nitroglycerin and send blood pressure to unsafe lows. People with diabetes, high blood pressure, high cholesterol, or heart disease often already take nitrates, which raises their exposure to that risk.
Anyone with ACTRA-Sx 500 should stop taking it and send it back for a refund. It is not known whether the recall was closed, completed or reopened.
Latest ACTRA-Sx Recall Updates
October 12, 2018: Study Reviews Tainted Supplements Including ACTRA-Sx’s Drug
JAMA Network Open published a study of dietary supplements the FDA identified as tainted with hidden drugs from 2007 through 2016[1]. Researchers reviewed 776 adulterated products in total. Most were marketed for sexual enhancement or weight loss.
Of those, 46.4% had already been tied to a voluntary recall, the same kind of action that later covered ACTRA-Sx 500’s undeclared ingredient.
September 12, 2012: Body Basics Recalls ACTRA-Sx 500 over Undeclared Drug
Body Basics Inc. announced a voluntary nationwide recall of ACTRA-Sx 500 Dietary Supplement Capsules, Lot 008-A[2]. Independent lab testing had confirmed the capsules contained sildenafil citrate, a prescription drug ingredient the label did not disclose.
The company had already stopped distributing ACTRA-Sx 500 in November 2011, months before the formal notice. Body Basics said regulators were aware of the action when it was announced.
Which ACTRA-Sx Are Affected?
The recall covers one batch of ACTRA-Sx 500, identified by the details below:
- Product: ACTRA-Sx 500 Dietary Supplement Capsules
- Lot number: 008-A
- UPC code: 830733002015
- Expiration date: December 2013
- Appearance and packaging: Purple and gold capsules, sold in bottles of 5
Body Basics Inc. sold ACTRA-Sx 500 only through independent distributors in the Los Angeles, California area and directly to a small number of consumers. The company never listed the product for sale online.
The lot number and expiration date are printed on the bottom of the bottle. The UPC code usually sits on a side panel next to the barcode.
Why Was ACTRA-Sx Recalled?
ACTRA-Sx 500 was recalled because independent laboratory testing commissioned by Body Basics Inc. found it secretly contained sildenafil citrate, the same drug used in prescription erectile-dysfunction medication, without warning on the label.
The undeclared ingredient made ACTRA-Sx 500 an unapproved drug under FDA rules rather than a mislabeled supplement. Sildenafil citrate is the drug the FDA has approved for prescription use to treat erectile dysfunction, according to MedlinePlus[3].
Because ACTRA-Sx 500 was sold as a dietary supplement, buyers had no way to know they were taking a prescription drug. Body Basics Inc. said the recall was carried out with the FDA’s knowledge.
Reported Incidents, Injuries, or Illnesses
No adverse reactions or other health problems had been reported to Body Basics Inc. as of the company’s September 12, 2012 recall notice. That does not rule out reactions that were never reported to the company or to the FDA.
Body Basics Inc. said there was no practical or economical way to tell which individual bottles were contaminated, so it asked anyone holding Lot 008-A to return the product.
Anyone who took ACTRA-Sx 500 while using a nitrate medication, or who noticed an unusual reaction afterward, should tell a doctor. They can also file a report with the FDA’s MedWatch program at any time.
What Should Consumers Do?
Anyone who has or may have ACTRA-Sx 500 Dietary Supplement Capsules should take the following steps:
- Stop taking ACTRA-Sx 500 immediately, even if the bottle looks unopened.
- Check the bottle for Lot 008-A and an expiration date of December 2013.
- Return any unused capsules to Body Basics Inc. for a full refund.
- Call Body Basics Inc. at 800-595-2718 for return instructions.
- Or report the product online through the FDA’s MedWatch program at www.fda.gov/medwatch/report.htm.
- Watch for symptoms such as flushing, headache, or a sudden drop in blood pressure.
- Get immediate medical care for chest pain, fainting, or sudden vision or hearing loss.
- Tell a doctor about ACTRA-Sx 500 before taking any nitrate medication, such as nitroglycerin.
Frequently Asked Questions
Is the ACTRA-Sx Recall Still Active?
No source found in this review confirms whether the ACTRA-Sx recall is still active. The FDA’s original 2012 recall page is no longer online, and no newer FDA notice mentions ACTRA-Sx. The September 12, 2012 announcement remains the only recall record found.
What Are the Symptoms of a Sildenafil Interaction from ACTRA-Sx 500?
Sildenafil, the drug found in ACTRA-Sx 500, can cause headache, flushing, nausea, and changes in color vision. More serious signs include sudden vision or hearing loss, ringing in the ears, chest pain, fainting, and an erection lasting more than four hours. Anyone with these symptoms should seek care right away.
Is the Sildenafil in ACTRA-Sx the Same Drug Used in Viagra?
Yes, the sildenafil in ACTRA-Sx 500 is the same active ingredient sold under the FDA-approved brand names Viagra, Revatio, and Liqrev. Those approved products carry dosing instructions and drug-interaction warnings that the ACTRA-Sx label did not.
What Did the 2018 Study Find About Supplements Like ACTRA-Sx?
The 2018 study of supplements like ACTRA-Sx found sildenafil was the most common hidden drug among the 776 products the FDA had flagged as tainted since 2007, with 97.6% never disclosed on the label.
How Do I Report a Problem with ACTRA-Sx to the FDA?
To report a problem with ACTRA-Sx to the FDA, use the MedWatch program. You can file online, by mail on Form FDA 3500, or by fax to 1-800-FDA-0178. You can also call Body Basics Inc. directly at 800-595-2718.
Does the FDA Test All Dietary Supplements Like ACTRA-Sx Before They Reach Stores?
No, the FDA does not test all dietary supplements like ACTRA-Sx before they reach store shelves. Researchers who reviewed the FDA’s tainted-supplement data found the agency can only test a portion of the products sold in the United States.