March 7, 2021

FDA Sends Warning to Makers of CRAZE Dietary Supplement

Driven Sports Inc. has some new supplements it would like to start selling, but after its product, CRAZE, was found to contain an unapproved meth-like ingredient, the U.S. Food and Drug Administration (FDA) says it will need some information first. In a warning letter to the company dated April 4, the FDA outlined next steps for the company. CRAZE, which was marketed as a sports supplement, contains "Dendrobex", which is listed on the product label as an ingredient and  N,α-diethylphenylethylamine, the meth-like ingredient, which is not. Neither chemical is approved for use in dietary supplements, so the presence of either one renders product adulterated, according to the FDA. The company has both disputed claims that CRAZE contains N,α-diethylphenylethylamine and cited claims that … [Read more...]

SNI Recalls Kratom Dietary Supplements for Undeclared Drugs

SNI National is recalling all Kratom products because they contain Kratom (Mitragyna Speciosa), which is a new ingredient for which there is "inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury." Scientific literature shows serious concerns about the toxicity of Kratom in organ systems. Consumption of these products may lead to "respiratory depression, nervousness, agitation, aggression, sleeplessness, hallucinations, delusions, tremors, loss of libido, constipation, skin hyperpigmentation, nausea, vomiting, and severe withdrawal signs and symptoms," according to the FDA release. The primary ingredient doesn't fall under the Federal Food, Drug, and Cosmetic Act as having all the information … [Read more...]

Pain Free by Nature Recalling Reumofan Plus Tablets

Pain Free by Nature of C0lorado is recalling "Reumofan Plus" Tablets because they contain the undeclared active pharmaceutical ingredients methocarbamol and diclofenac. Taking this product could result in serious and life-threatening injuries. Methocarbamol is a muscle relaxant available only by prescription. Diclofenac is a prescribed NSAID that can cause sudden heart attacks, strokes, bleeding ulcers, and holes in the stomach and intestine. Reumofan Plus is a treatment for muscle pain, arthritis, osteoporosis, bone cancer, and other medical conditions. The product is packaged in a green and gold box in 30 tablet containers. It was distributed nationwide through internet sales. The recall was initiated after the FDA discovered the packaging didn't reveal the presence of the active … [Read more...]

Weight Loss Supplement Fruta Planta Recalled for Unapproved Drug

MyNicKnaxs of Florida is recalling Reduce Weight Fruta Planta because it contains Phenolphthalein, making the supplement an unapproved new drug. Phenolphthalein was once used in over the counter laxatives, but it was banned because of concerns of carcinogenicity. Consumption of this product could cause serious gastrointestinal disturbances, irregular heartbeat, and cancer. All lots of Reduce Weight Fruta Planta are recalled. The product contains 10.2 mg of Phenolphthalein. No illnesses or injuries have been reported to date. If you purchased this product, stop using it immediately. Return it to the place of purchase for a refund. If you have experienced side effects or adverse reactions associated with this product, report to FDA's MedWatch Adverse Event Reporting program. … [Read more...]

Adipotrim XT Recalled for Unapproved Drug

The dietary supplement Adioptrim XT is being recalled because it contains undeclared fluoxetine, or Prozac, which is a drug that needs a doctor's prescription. That makes the supplement an unapproved drug. Fluoxetine can cause sudden death in some patients who have heart conditions, blood clots, psychosis, and are on chemotherapy. It can also cause suicidal thinking, abnormal bleeding, and seizures. No injuries or illnesses have been reported to date. Adipotrim XT is marketed as a natural herb dietary supplement for weight loss. The recalled product is packaged in 30 count plastic bottles labeled with lot number #052012. The product lot was sold directly to individual customers from the Deseo Rebajar Inc. offices in Fajardo, Caguas and Bayamon and through the company's website. If … [Read more...]

Freedom Trading Recalls Super Power for Undeclared Hazardous Ingredient

D&S Herbals, LLC, doing business as Freedom Trading is recalling a dietary supplement called Super Power, which supports male sexual performance. The product contains trace amounts of sildenafil, the active pharmaceutical ingredient in an FDA approved drug used to treat erectile dysfunction. Sildenafil may interact with nitrates found in some medications (such as nitroglycerin) and lower blood pressure to dangerous levels. It can also cause side effects such as headaches and flushing. There have not been any reports of adverse reactions or injury related to this recall. The recalled product, Super Power, has expiration date of 06/2015 and Batch Lot number L08108. It is in capsule form, packaged in two count blister packs. It was sold between August 2012 and January 2013 … [Read more...]

Dangerous Supplement Now Sold as “WOW”

The Food and Drug Administration (FDA) is warning the public that a product distributed and sold under the name "WOW" is another banned product in disguise. Earlier this year, the FDA warned the public about taking Reumofan Plus, which was marketed as a "natural" dietary supplement for the treatment of arthritis and bone cancer. It contained undeclared active ingredients found in prescription drugs that should be used only under the supervision of a health care professional. Apparently, some distributors have deliberately put a new label and new name, WOW, on bottles of Reumofan Plus to deceptively sell remaining supplies. It was distributed to online retailers and other distributors, as well as directly to consumers. Since June, the FDA has received dozens of reports of serious and … [Read more...]

Performance Plus Marketing Recalling Supplements for Unapproved New Drugs

Performance Plus Marketing is recalling Libigrow®, Libigrow XXXtreme®, Blue Diamond®, Blue Diamond Platinum®, Mojo Nights®, Mojo Nights Supreme®, and Casanova® because they contain undeclared Sulfoaildenafil and Thioaildenafil. Those are analogues of sildenafil, which is an FDA-approved drug for the treatment of male Erectile Dysfunction. That makes the recalled products unapproved new drugs. You can see all of the product names, UPC codes, packaging types, lot numbers, and expiration dates at the FDA web site. The unapproved drugs are close in nature to sildenafil and are a threat to some consumers. The drugs may interact with nitrates found in some prescription drugs and may lower blood pressure to dangerous levels. The recall includes ALL authentic lot numbers and known to be … [Read more...]

Zi Xiu Tang Success Recalls Capsules for Unapproved New Drugs

Zi Xiu Tang Success LLC is recalling four lots of Classic Xi Xiu Tang Bee Pollen Capsules and three lots of Ultimate Formula Capsules because they contain undeclared Sibutramine. This is a previously controlled substance that was removed from the U.S. market in October 2010 for food safety reasons. This drug increases blood pressure and/or pulse rate in some patients and may present a significant health risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke. The Bee Pollen product is marketed as a dietary supplement used as a weight loss aid. It is packaged in bottles of 60 capsules. The UPC number is 6937000700019 with lot numbers 04/15/2012, 05/15/2012, 06/15/2012 and 07/15/2012. It was distributed from May 1 to October 17, 2012 … [Read more...]

Healthy People Co. Expands Voluntary Recall

The February 2, 2012 recall of dietary products by Healthy People Co. is being expanded. The brand names of the recalled products are listed below. This update recalls all listed products regardless of their lot number. The products were sold on or before October 25, 2011 and were distributed nationwide. The products may contain Sibutramine and Tadalafil, which are FDA-approved drugs. The presence of those drugs in these products makes the products unapproved new drugs. Sibutramine has been withdrawn from the U.S. market because people taking it had an increased risk of heart attack and stroke. For more information about the drugs and their inclusion in these products, please see the previous recall. Product details: MINCE BELLE (Dietary Supplement) 30 capsules UPC Number … [Read more...]

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