September 28, 2021

Search Results for: unapproved drugs

Sundial Herbal Products Recalled For Unapproved Drugs and Misbranding

Sundial Herbal Products are being recalled for unapproved drugs to be in compliance with FDA Drug Regulations. These recalled products are misbranded because they have labeling claims that could result in delay of appropriate treatment by a healthcare provider. Because these dietary supplements are unapproved, their safety and efficacy have not been established. No illnesses or adverse reactions have been reported by the company to date. The recall headline states that "recall is required by the order." All products used as Sundial Herbs can be identified with the "Sundial" label. They were sold in brown glass bottles, boxes, ziplock bags, and  paper bags wit clear viewing windows. They were distributed nationwide or statewide through the Sundial Herb website or any other website. … [Read more...]

FDA Finds Bitter Orange Supplements Can Contain Unapproved Drugs

The FDA has released a study that finds some bitter orange dietary supplements can contain unapproved drugs. This supplement is sold as a sports performance supplement and weight management supplement. It became popular after Ephedra products, a type of amphetamine, were banned from the U.S. after it was linked to heart attacks, strokes, seizures, and sudden deaths. But as Consumer Reports points out, the government agency hasn't begun enforcement action against the companies that make these products, nor has it warned consumers about them. Manufacturers claim that bitter orange supplements increase energy and suppress appetite. The bitter orange supplements can contain synephrine, an amine, which can cause adverse cardiovascular events, especially when taken with caffeine. For … [Read more...]

Permanent Injunction Against Sundial Herbal Products For Unapproved Drugs

A federal judge has entered an order of permanent inunction against Sundial Herbal Products to stop distributing their products because they have been labeled unapproved new drugs and misbranded drugs. Despite previous warnings from the FDA, the company "continued to violate the law and distributed their products," according to a new release issued by the FDA. FDA Chief Counsel Stacy Amin said in a statement, "Americans expect and deserve medical treatments that have been scientifically proven to be safe and effective. Making claims that unproven drugs can cure or prevent diseases places consumers’ health at risk. We remain committed to pursuing and taking swift action against those who attempt to subvert the regulatory functions of the FDA by repeatedly disregarding the law and … [Read more...]

Rhino 5K Capsules Recalled for Unapproved Drugs

Happy Together, a company in Boynton Beach, Florida, is recalling all lots of Rhino 5K capsules because they are tainted with sildenafil and Tadalafil. Sildenafil and Tadalafil are FDA approved drugs that are available only through prescription. Those drugs render the product as a whole an unapproved drug for which efficacy and safety has not been established, therefore subject to recall. No adverse reactions have been reported to date in connection with this recall. Men with diabetes, high blood pressure, heart disease, or high cholesterol may be taking prescription meds that could interact with these products and cause dangerously low blood pressure that could be life-threatening. The company can't identify customers who bought this product, so they are making a public announcement … [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...]

Megajex Dietary Supplement Recalled for Unapproved Drugs

MS Bionic is recalling all lots of Megajex Natural Male Sex Enhancer capsules. this product contains Tadalafil and Sildenafil, FDA approved drugs used as treatment for ED. This product could be harmful because these undeclared drugs may lower blood pressure to dangerous levels. Anyone with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. The drugs in this product can interact with nitrates. The product is marketed as a dietary supplement for erectile dysfunction. It is packaged in 20 count bottles and was sold nationwide. If you purchased this product, do not take it. Contact your physician if you have experienced any problems that may be related to taking or using this product. Return the product to the place of purchase or take it to a drug … [Read more...]

Skinny Bee Diet Recalled for Unapproved Drugs

Love my Tru Body of Georgia is recalling all of its Skinny Bee Diet pills after FDA testing found it contained sibutramine, desmethylsibutramine, and phenolphthalein. Sibutramine is an appetite suppressant that was withdrawn from the U.S. market in October 2010. Desmethylsibutramine is an active metabolite of sibutramine. Sibutramine and its active metabolites substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke. Phenolphthalein was previously used in over-the-counter laxatives, but because of concerns of carcinogenicity, it is no longer marketed in the U.S. These undeclared ingredients make this product an unapproved new drug … [Read more...]

SOS Telecom Recalls Unapproved Drugs Sold as Dietary Supplements

SOS Telecom is recalling unapproved drugs marketed and sold as dietary supplements. All lots of these products are recalled because they contain Sildenafil, a PDE-5 inhibitor which is the active ingredient in an FDA-approved drug for erectile dysfunction. SIldenafil can interact with nitrates in some prescription drugs and can lower blood pressure to dangerous levels. The recalled products are Tiger-X, lot number 9236999, with best use by date of 12/16/2016. It is sold in 1 capsules per pack/24 single packs per box. Also recalled is Ninja-X with lot number 7920888 and best use by date of 6/31/2018. It is also sold in ` capsules per pack/24 single packs per box. Ginseng Power-X, with lot number 7788965 and best use by date of 10/15/2018 is also recalled .That product is sold in 1 … [Read more...]

Fuel Up Dietary Supplements Recalled for Unapproved Drugs

Reesna is voluntarily recalling all lots of Fuel Up Plus and Fuel Up High Octane dietary supplements because they contain hydroxythiohomosildenafil, an analogue of sildenafil. This drug is used for the treatment of male Erectile Dysfunction, making the supplement an unapproved drug. They were distributed in August 2015. Hydroxythiohomosildenafil poses a threat to consumers because it can interact with nitrates found in prescription drugs and lower blood pressure to dangerous levels. People who have diabetes, high blood pressure, high cholesterol, or heart disease often take nitrate-containing drugs. No illnesses or injuries have been reported to date in connection with the consumption of this product. If you purchased these products, do not consume them. Return to the place of … [Read more...]

Why Do Some Supplements Contain Unapproved Drugs?

The Department of Justice and its federal partners is announcing a nationwide sweep and enforcement actions against some dietary supplement makers. More than 100 of those facilities have been investigated in the past year. One of the main reasons for these recalls is that the products contain drugs that have been removed from U.S. markets. Why are these products being sold with unapproved drugs? This year-long effort focused resources on facilities that sold supplements that contain ingredients other than those listed on the label, or the sale of products that make health claims unsupported by scientific evidence. One of the criminal cases announced charges against USPlabs LLC, maker of OxyElite Pro and Jack3d, along with several of its officers. In 2013, OxyElite Pro was recalled by … [Read more...]

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