The U.S. District Court for the District of New Jersey has entered an order of permanent injunction against S. Hackett Marketing LLC doing business as Just Enhance. This injunction requires the defendants to cease the distribution of their products until they take remedial measures and comply with the Federal Food, Drug, and Cosmetic Act. The notice states that the defendants violated the Act by selling unapproved drugs and misbranded drugs to consumer on more than 100 different websites. The complaint states that the label on these products claimed, without FDA approval or any clinical studies demonstrating safety and effectiveness, that they could treat or provident serious conditions. Some of those conditions included impotence and prostatitis. Testing at the FDA laboratory … [Read more...]
Permanent Injunction Issued Against Dietary Supplements Containing Undisclosed Drugs
Sienna Laxative and Flawless Beauty Recalled for Mislabeling and Unapproved New Drug
Two products regulated by the FDA have been recalled; one, Sienna Laxative, for mislabeling, and the other, Flawless Beauty products, because it contains an unapproved new drug. No illnesses or adverse reactions have been reported. The first recall is for Flawless Beauty products. In accordance with a Consent Decree of Permanent Injunction, the company is voluntarily recalling all lots of 19 different products that were sold individually or as part of multi-unit kits because they are unapproved new drugs. These products were sold over the internet to U.S. and foreign customers. All glutathione products were sold in multi-vial whitening kits. The FDA believes that these drugs present serious public health risks. You can see the long list of recalled products at the FDA web site. … [Read more...]
Marmex Corporation Recalls Blue Pearl Dietary Supplement for Undeclared Sildenafil
Marmex Group is voluntarily recalling all lots of Blue Pearl All Natural Male Enhancement Supplement because the product contains sildenafil, which makes it an unapproved drug. Products with undeclared sildenafil may pose a threat to consumers because the active ingredient can interact with nitrates in some prescription drugs and lower blood pressure to dangerous levels. No adverse effects have been reported to date in connection with this issue. Consumers with high blood pressure, diabetes, high cholesterol, or heart diseases often take nitrates and may be the most likely to be affected by this undeclared drug. The safety and efficacy of this product has not been established. The recalled products is Blue Pearl All Natural Male Enhancement Supplement capsules in 500 mg packages. … [Read more...]
FDA Warns Companies That Make Coco Loko and Legal Lean as Unapproved New Drugs
The FDA is warning makers and manufacturers of two products, Legal Lean Syrup, a drink, and Coco Loko, a "snortable" chocolate powder, for selling unapproved new drugs and misbranded drugs. These products are promoted as alternatives to street drugs. The government has sent a warning letter to one company about this problem. Claims made in the promotional materials for the products demonstrate they are intended to be used as alternatives to street drugs. These products, as labeled and marketed, "may pose safety concerns," according to the press release. The FDA is concerned that these products encourage drug abuse in individuals, including minors. These street drug alternatives are used for recreational purposes to affect psychological states. FDA Commissioner Scott Gottlieb said … [Read more...]
Nutra Labs Recalls Dietary Supplements for Undeclared Drugs
Nutra Labs is voluntarily recalling two dietary supplements because they contain sildenafil, the active pharmaceutical ingredient in an FDA approved product used for erectile dysfunction. This makes these supplements unapproved new drugs. No illnesses or reactions have been reported to date in connection with this problem. The recalled products are Bull in 1800 mg capsules with a production date of 05/08/2016 and Chao Jimengnan 150 mg tablets with lot #20151018. FDA analysis found that Bull had contamination of 0.026mg/capsule, and 70.46 mg/table for Chao Jimengnan. The expiration dates are 05/07/2019 for Bull and 10/2017 for Chao Jimengnan. This drug can be dangerous because its active ingredient may interact with nitrates found in some prescription drugs, such as nitroglycerin. … [Read more...]
New Kopi Jantan Natural Herbs Coffee Recalled for Undeclared Drugs
Bestherbs Coffee LLC is voluntarily recalling all lots of New of Kopi Jantan Tradisional (sic) Natural Herbs Coffee, a dietary supplement, because it contains an undeclared ingredient and undeclared milk. Desmethyl carbodenafil is structurally similar to sildenafil, the active ingredient in Viagra, which makes this product an unapproved drug. That ingredient can interact with nitrates found in prescription drugs and lower blood pressure to dangerous levels. The product also contains undeclared milk, which can sicken those who are allergic to that ingredient. New of Kopi Jantan Tradisional Natural Herbs Coffee is used as a male enhancement and is packaged in 13 gram red packs, with UPC number 557205060083. Each box contains 25 packets. Bestherbs Coffee LLC distributed this product … [Read more...]
Sten Z and M1 Alpha Supplements Recalled for Steroids
Andropharm is recalling all lots of Sten Z and M1 Alpha capsules because they contain derivatives of anabolic steroids. This makes these products unapproved drugs, for which safety has not been established. No reports of adverse reactions have been received to date. These product may cause elevated blood pressure, aggressive behavior, male infertility. Those with conditions such as heart disease, liver disease, or prostate issues can be at higher risk. Sten Z and M1 Alpha capsules are marketed as dietary supplements and promoted to increase, sustain, and strengthen muscularity. The two products were packaged as capsules in 60 count bottles with the UPC number 642125502948 (Sten Z) and UPC number 642125502924 (M1 Alpha). These products were sold through retailers nationwide in the … [Read more...]
Ultra-Sten and D-Zine Supplements Recalled for Anabolic Steroids
Hardcore Formulations is recalling all lots and expiration dates of Ultra-Sten and D-Zine capsules because they contain anabolic steroids. The presence of these drugs render them unapproved drugs and subject to recall. No illnesses or adverse effects have been reported to date. Ultra-Zen contains methylstenbolone and D-Zine contains dymethazine. These drugs can cause serious liver injury and also injure the kidneys, cause an increased risk of heart attack and stroke, elevated blood pressure, and other issues. Ultra-Sten and D-Zine capsules are marketed as dietary supplements for body-building and are packaged in 90-count bottles, with the bar code 7-48252-68763-0 (Ultra-Sten); 7-48252-86193-1 (D-Zine) and sold through retailers nationwide in the USA. This recall applies to all lot … [Read more...]
Tri-Ton Recalled for Unapproved Drugs
Dynamic Technical Formulations is voluntarily recalling all lots of Tri-Ton, a dietary supplement. FDA lab analysis found that it contains mandarine and ostarine, which are selective androgen receptor modulators (SARMs) that are considered unapproved drugs and anabolic steroid-like substances. Use of those substances may cause acute liver injury. Other long term adverse health effects in men, women, and children include male infertility, short stature in children, a higher risk of misusing other drugs and alcohol, and increased risk of heart attack, stroke, and death. The recalled product, Tri-Ton, was sold in 90 count bottles. All lot numbers and expiration dates are recalled. It was sold through retailers nationwide. Shipment was from June 2016 to March 2017. Stop using this … [Read more...]
GEC Laxoplex Recalled for Anabolic Steroids
Genetic Edge Compounds is voluntarily recalling all lot codes of GEC Laxoplex that were distributed between February 2, 2015 and May 2, 2017 because they are tainted with anabolic steroids and steroid-like substances. This makes the supplement an unapproved drug. There have been no reports of adverse effects received to date. Anabolic steroids an cause acute liver injury and can cause other adverse health problems, including a higher predilection to misuse other drugs and alcohol, and increased risk of heart attack, stroke, and death. The recalled product is GEC Laxoplex. It is marketed as a dietary supplement and sold as a muscle enhancing agent. It is packaged in a white plastic bottle containing 60 capsules. The UPC number is 0058049984. It was distributed nationwide through … [Read more...]
