Gaspari Nutrition Issues a Nationwide Recall of Novedex XT, a Product Marketed as a Dietary Supplement Containing ATD
What’s the problem?
October 8, 2010 - Gaspari Nutrition Incorporated announced this week that it is conducting a nationwide recall of all Lot Codes of the company's dietary supplement product sold under the name Novedex XT, which was marketed "for increasing natural testosterone production" and contains 3,17-keto-etiocholetriene, also known as ATD, an anti-aromatase.
Gaspari Nutrition is conducting this consumer level recall after being informed by representatives of the Food and Drug Administration (FDA) that 3,17-keto-etiocholetriene does not meet the definition of a dietary ingredient and therefore the product is in violation of provisions of the Federal Food, Drug, and Cosmetic Act.
ADT Supplement Side Effects
Potential adverse events associated with the use of anti-aromatases could include the following:
- decreased rate of bone maturation and growth
- decreased sperm production
- infertility
- aggressive behavior
- adrenal insufficiency
- kidney failure
- liver dysfunction
Consumers with liver, kidney, adrenal, or prostate abnormalities are at higher risk for developing adverse events. Novedex XT had been sold internationally and domestically, to distributors, wholesalers, retail stores and direct to consumers, but was discontinued by Gaspari Nutrition for domestic sales on October 4th, 2010.
The product was sold in blue bottles with a black cap, containing sixty (60) capsules.
What Does Novedex XT Do?
Novedex XT is designed to provide post-cycle therapy (PCT) by reducing potential estrogen increases after a steroid cycle, while also increasing testosterone to better allow you to keep muscle and strength gains.
How Does Novedex Affect Testosterone?
Novedex works by occupying the enzyme aromatase, which means it can't be used to convert testosterone into estrogen. One small study on fit and healthy men found that, when dosed at 300 mg per day, participants' testosterone levels had elevated by an average of just under 90% after 8 weeks.
What Happens if Men Take Novedex?
Hot flashes, nausea, leg cramps, muscle aches, hair thinning, headache, and numb/tingling skin may occur when taking Novedex. A loss of sexual ability/interest may also occur in some men. If these side effects persist or get worse, consult your physician immediately.
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Do I have a Nutritional Supplement Drug Recall Lawsuit?
The Defective Drug Litigation Group at Schmidt & Clark, LLP law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in defective dietary supplement recall lawsuits. We are handling individual litigation nationwide and currently accepting new cases in all 50 states.
Free Dietary Supplement Recall Case Evaluation: If you or a loved one has been injured by Novedex XT Dietary Supplements included in this recall, you should contact our law firm immediately. You may be entitled to compensation by filing a lawsuit and we can help.