June 19, 2024

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...]

Mega Slim Dietary Supplement Recalled for DMAA

YoungYou International is recalling Mega Slim Herbal Appetite Management, a dietary supplement, because it contains DMAA. DMAA, also known as 1,3-dimethylamylamine, methylhexanamine, or geranium extract, is dangerous to your health. It can cause a rise in blood pressure or other cardiovascular problems such as shortness of breath, tightening in the chest, or heart attack. The chemical is an unapproved dietary ingredient. Mega Slim Herbal Appetite Management is packaged in white bottles with 30 white capsules. The lots include the bar code 736211614094 and an expiration date of June 2014. The product was only sold through the YoungYou web site. If you purchased this product, do not take it. Return it to the company for a refund. The company is only issuing refunds to customers who … [Read more...]

Dietary Supplements Can’t Treat Concussion

The FDA is warning consumers that, despite claims to the contrary, dietary supplements can't treat concussion. Some companies are offering "untested, unproven and possible dangerous products that claim to prevent, treat or cure concussions and other traumatic brain injuries (TBIs). FDA is monitoring the marketplace and taking enforcement action where they feel it is appropriate. They will issue warning letter to companies as necessary as the first step. Warning consumers is another step. Finally, the FDA can go to the courts and get an injunction against a corporation making supplements with unproven or misleading claims, forcing them to stop production and recall the product. One common claim made by some corporations is that using a particular dietary supplement can promote faster … [Read more...]

Burn 7 Capsules Recalled for Undeclared Sibutramine

Deseo Rebajar, Inc. is recalling Burn 7 Capsules, a dietary supplement to promote weight loss, because it contains undeclared Sibutramine. That is a previously controlled substance that was removed from the U.S. market in October 2010 for safety reasons. The drug substantially increases blood pressure and/or pulse rate in some people. It may present a significant risk to patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke. The recalled product is Burn 7 capsules with lot #MFD: 07.18.2013 (Exp: 07.17.2015). The product was sold directly to customers from the company offices in Fajardo, Caguas and Bayamon, and through the company's website. If you purchased this product, do not use it. Return it to the place of purchase for a refund. If … [Read more...]

FDA Warning Consumers Against Mass Destruction Supplement

The FDA is warning consumers to immediately stop using a product called Mass Destruction, marketed as a dietary supplement for muscle growth. The product is labeled to contain at least one synthetic anabolic steroid and has been linked to at least one reported serious illness. The FDA was alerted by the North Carolina Department of Health and Human Services of a serious injury associated with use of this product. A previously healthy 28-year-old male developed liver failure and requires a liver transplant after just several weeks of product use. Liver injury can happen when using products that contain anabolic steroids and steroid-like substances. Mass Destruction is manufactured for Blunt Force Nutrition in Sims, North Carolina and is sold in retail stores, fitness gyms, and on the … [Read more...]

Zanocap Capsules Recalled for Undeclared Milk

Stone Independent Research of New York is recalling 1,040 units of Zanocap Scientific Weight Loss 500 mg capsules because it contains whey protein, which is milk, that is not declared on the label. Anyone with an allergy or sensitivity to milk could have a serious or life-threatening reaction if they consume this product. No illnesses have been reported to date. Zanocap was sold to one customer who distributed it nationwide through internet sales. The affected lot was distributed beginning June 1, 2013. The dietary supplement is packaged in a white plastic bottle containing 90 capsules. The product label is white with blue and black print. The lot code is 10W15013 with an expiration date of 05/2015. The issue was discovered during an FDA inspection of the production facility. If you … [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...]

OxyElite Pro Dietary Supplements Recall for Liver Damage Expands

The recall of OxyElite Pro dietary supplements by USPlabs has expanded. The products include Aegeline, a synthesized version of a natural extract from the Bael tree. This ingredient can cause hepatitis and serious liver damage or liver failure. One person has died after taking these supplements, and others have had liver failure and either received liver transplants or are waiting for them. The ill persons live mainly in Hawaii. You can see the long list of recalled products at the FDA web site. You can also see photos of product labels at the FDA site. The products were distributed nationwide through retail stores, mail order, and direct delivery. Recalled products include OxyElite Pro Super Thermo capsules, OxyElite Pro Ultra-Intense Thermo capsules, and OxyElite Pro Super Thermo … [Read more...]

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