Gaspari Nutrition Incorproated, 575 Prospect Street - Suite 230, Lakewood, NJ, announced today that it is conducting a voluntary 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.
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, and liver dysfunction. Consumers with liver, kidney, adrenal, or prostate abnormalities are at higher risk for developing adverse events. Gaspari has received no serious adverse events in over five years of marketing Novadex XT.
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.
Consumers who have Novedex XT in their possession should stop using it immediately. If consumers experience any adverse side effects due to consumption of this product, they should immediately contact a physician.
Showing posts with label GeneScience. Show all posts
Showing posts with label GeneScience. Show all posts
GeneScience of China ( maker of Jintropin HGH ) pleads guilty in US court gets $7.5 million fine.
A Chinese company and its chief executive have agreed to plead guilty to federal charges of illegally selling human growth hormone and will pay a total $7.5 million.
Lei Jin and his company, Genescience Pharmaceutical Co., were scheduled to enter the guilty pleas and be sentenced Wednesday in U.S. District Court in Providence, R.I. The company has agreed to plead to a felony and Jin to a misdemeanor, according to court documents.
Genescience Pharmaceutical sold the drug under the brand name Jintropin without approval from the Food and Drug Administration. The firm was charged in 2007 during a massive crackdown on illegal sports doping, dubbed Operation Raw Deal, in which 120 people were arrested, and 11.4 million doses of drugs were seized.
The investigation crippled the company, which the government believes is responsible for nearly 90 percent of the illegal human growth hormone found in the United States, said Jason Simonian, a special agent with the Food and Drug Administration. Investigators used wire transfers and e-mails from the company to track shipments across the world, Simonian said.
"We've vertically taken out every step of the process," Simonian said. "It shows the bad guys that no matter where they are in the world, we have the ability to reach out and take their money, and I think that's one of the most significant parts of the case."
As part of the plea agreement, the company and the executive will forfeit $4.5 million and set up a $3 million fund that will work against doping in sports by providing grants for education and scientific research. The fund will be administered by the Rhode Island Foundation.
Lawyers for the company and for Jin did not immediately return calls seeking comment.
The FDA closely regulates the use of human growth hormone, allowing it to be prescribed for certain medical conditions but not for anti-aging, bodybuilding or weight loss.
Jintropin is widely used to build muscle mass and, in 2007, actor Sylvester Stallone was convicted of importing dozens of vials of the drug into Australia. He later defended its use.
Lei Jin and his company, Genescience Pharmaceutical Co., were scheduled to enter the guilty pleas and be sentenced Wednesday in U.S. District Court in Providence, R.I. The company has agreed to plead to a felony and Jin to a misdemeanor, according to court documents.
Genescience Pharmaceutical sold the drug under the brand name Jintropin without approval from the Food and Drug Administration. The firm was charged in 2007 during a massive crackdown on illegal sports doping, dubbed Operation Raw Deal, in which 120 people were arrested, and 11.4 million doses of drugs were seized.
The investigation crippled the company, which the government believes is responsible for nearly 90 percent of the illegal human growth hormone found in the United States, said Jason Simonian, a special agent with the Food and Drug Administration. Investigators used wire transfers and e-mails from the company to track shipments across the world, Simonian said.
"We've vertically taken out every step of the process," Simonian said. "It shows the bad guys that no matter where they are in the world, we have the ability to reach out and take their money, and I think that's one of the most significant parts of the case."
As part of the plea agreement, the company and the executive will forfeit $4.5 million and set up a $3 million fund that will work against doping in sports by providing grants for education and scientific research. The fund will be administered by the Rhode Island Foundation.
Lawyers for the company and for Jin did not immediately return calls seeking comment.
The FDA closely regulates the use of human growth hormone, allowing it to be prescribed for certain medical conditions but not for anti-aging, bodybuilding or weight loss.
Jintropin is widely used to build muscle mass and, in 2007, actor Sylvester Stallone was convicted of importing dozens of vials of the drug into Australia. He later defended its use.
Pharmacy in earlier investigation alleged to be part of international smuggling network.
An Orlando pharmacy whose operators were snared nearly three years ago in an Albany County criminal probe has been implicated in an international network that federal authorities say smuggled human growth hormone from China to the United States, court records show.
The role of Florida's Signature Compounding Pharmacy in the distribution of human growth hormone is highlighted in a partially sealed federal criminal case in Rhode Island that was never announced by the Justice Department.
Signature's alleged role in the wider federal case comes as an appellate court in Albany is set to rule soon on whether state criminal charges against the pharmacy's operators should be reinstated here.
The role of Florida's Signature Compounding Pharmacy in the distribution of human growth hormone is highlighted in a partially sealed federal criminal case in Rhode Island that was never announced by the Justice Department.
Signature's alleged role in the wider federal case comes as an appellate court in Albany is set to rule soon on whether state criminal charges against the pharmacy's operators should be reinstated here.
Signature pharmacy is identified in Effron's court papers by name and also as "pharmacy X." Two Florida physicians, Gary Brandwein and Claire Godfrey, who pleaded guilty to felony criminal charges in Albany related to prescriptions they wrote through Signature pharmacy, also are identified in Effron's criminal case.
The criminal charges against Effron detail his importing HGH from a Hong Kong company, GeneScience Pharmaceutical Co., whose founder, Lei Jin, was indicted on similar federal drug smuggling charges in Rhode Island two years ago. Jin pleaded not guilty and his case is pending.
"Pharmacy X was a licensed pharmacy located in Orlando, Florida," states an 18-page criminal information filed against Effron in June. "Pharmacy X contracted Effron to facilitate the smuggling of HGH from GPC in China to Florida."
Between 2004 and 2007 Effron, "acting on behalf of Pharmacy X," illegally imported more than $690,000 worth of HGH from China, court records show.
Effron and Lei Jin, who often used e-mails to discuss their importation of HGH, met at least three times in Orlando and China regarding their alleged conspiracy. "The owners of Pharmacy X were present during at least one of those meetings," prosecutors said in court filings.Pharmacy X and Effron took steps to conceal the origin of the HGH that was being imported (from China) because they knew that HGH manufactured by GPC was not an approved drug, that it was on the FDA seizure list, and that, in any event, Effron was not a licensed wholesale drug distributor," prosecutors wrote in Effron's criminal information.
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