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 … Read more
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 … Read more
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. … Read more
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 … Read more
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 … Read more
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 … Read more
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 … Read more
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 … Read more
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, … Read more
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 … Read more