February 26, 2020

Dietary Supplements Recalled for Undeclared Drugs

Detox Transforms Health and Nutrition is recalling five dietary supplements because they contain undeclared drugs. These drugs can cause serious health issues with long term use. No illnesses have been reported to date. The recalled items include INDIGO in 60 capsule white bottles with UPC number 852175004044, lot number 000034, and expiration 4/10/2017. Also recalled is EDGE Amplified Weight Release in 60 count white bottles with UPC number 852175004174; all lot numbers are recalled. AMPD Gold Bee Pollen in 60 capsules white bottles is recalled, with UPC number 852175004181; all lot numbers are recalled. BtRim Max in 60 capsule white bottles with UPC number 852175004068, lot number 00002, and expiration date 4/27/2017 is recalled. Finally, INSANE Bee Pollen in 60 count white bottles is … [Read more...]

SLIM-K and B-Lipo Supplements Recalled for Undeclared Drugs

Bethel Nutritional Consulting of New York is recalling SLIM-K Capsules and B-Lipo Capsules because they contain undeclared drugs. SKIM-K contains sibutramine, desmethylsibutramine, and Phenolphthalein. Sibutramine is an appetite suppressant removed from the U.S. market in October 2010 for increased risk of seizures, heart attacks, and strokes. Phenolphthalein is not approved for use in the U.S. because of concerns of carcinogenicity and causing irregular heartbeat. B-Lipo contains Lorcaserin, a controlled substance used for weight loss. Sibutramine can increase blood pressure and pulse rate and may interact in life threatening ways with other meds a consumer may be taking. Lorcaserin side effects including difficulty thinking, hallucinations, and feeling of intense excitement. The drug … [Read more...]

Bee Pollen Recalled for Undeclared Drugs

REFA Enterprises, LLC is voluntarily recalling Forever Beautiful Bee Pollen and Forever Beautiful Infinity because they contain undeclared Sibutramine or a combination of both Sibutramine and Phenolphthalein, discovered through FDA analysis. Sibutramine is an appetite suppressant that was removed from the U.S. market in October 2010 because of increased risk of seizures, heart attacks, arrhythmia, and strokes. Phenolphthalein is an ingredient that was used in over-the-counter laxatives, but because of concerns of carcinogenicity, it is not currently approved for use in this country. These undeclared ingredients make the products unapproved new drugs. The products can interact in life-threatening ways with other medications and can be dangerous on their own. Sibutramine can increase … [Read more...]

Mayhem Dietary Supplement Recalled for Unapproved Drug

Chaotic Labz of Arkansas is voluntarily recalling Mayhem dietary supplement capsules. This product is used as a bodybuilding supplement. FDA analysis found that it contains dexamethasone, a prescription corticosteroid used to treat inflammatory conditions, and cyproheptadine, a prescription antihistamine used for seasonal allergy treatments. These ingredients make this product an unapproved drug. The recalled product is Mayhem dietary supplement capsules with lot number CLM061114. It has an expiration date of 06/2016. It is packaged in a clear bottle with yellow capsules. It is identified by the brand known as Chaotic Labz and the product name Mayhem, Appetite for Construction. It was distributed nationwide to various Nutritional Supplement Retail Outlets and via the … [Read more...]

After Recalls, Dietary Supplements with Banned Drugs Stay on Market

About half of all FDA drug recalls in the last decade have been for dietary supplements that contain  banned ingredients. These recalls are meant to be swift enforcement actions that protect consumers from serious, sometimes life-threatening, conditions,  but in some cases these dangerous products remain on the market for longer than six months after they are recalled, according to a new report in the Journal of the American Medical Association (JAMA). For the study, Harvard researchers looked at supplements recalled between January 1, 2009 and December 31, 2012 that were still on the market with the same name, maker and distributor in July or August of 2013. Of the 274 dietary supplements recalled, 27 met these criteria. These recalled supplements, labeled as weight loss, sports … [Read more...]

FDA Issues Sit and Slim II Warning for Unapproved Drugs

The U.S. Food and Drug Administration (FDA) is advising consumers not to purchase or use Sit and Slim II which contains the unapproved drugs sibutramine and phenolphthalein. The product is marketed as a weight loss aid. Sibutramine was removed from the market in October 2010 for safety reasons. The product poses a health threat to consumers because it can substantially increase blood pressure and pulse rate. This poses serious problems for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke. The drug can also interact with other medications and cause a  life-threatening situation. Phenolphthalein is an unapproved drug in the United States. Studies have shown that it presents a cancer-causing risk. Health care professionals and … [Read more...]

U.S. Marshals Seize $5 Million of Raw Kratom

U.S. Marshals have seized more than 25,000 pounds of raw kratom material worth more than $5 million from Rosefield Management, Inc. in Van Nuys, California.  Kratom is a botanical substance native to Thailand, Malaysia, Indonesia and Papua New Guinea.  It is not approved in the U.S. for any medical use but is marketed for its opioid-like analgesic effects and in the treatment of morphine and heroin addiction. Consumption of kratom can cause health problems including respiratory depression, nervousness, agitation, aggression, sleeplessness, hallucinations, delusions, loss of libido, tremors, skin hyperpigmentation, nausea, vomiting, constipation and severe withdrawal signs and symptoms. “We have identified kratom as a botanical substance that poses a risk to public health and has the … [Read more...]

Nano Well-being Health Recalls Super Arthgold

La Mirada, Nano Well-being Health Inc. is recalling two lots of Super Arthgold, a dietary supplement marketed for joint pain and arthritis, because it contains chlorzoxazone, diclofenac, and indomethacin, making it an unapproved new drug. The FDA states that "use of this product has a reasonable probability of resulting in fatal adverse events in consumers with underlying illnesses." Those illnesses include allergies to the hidden ingredients, cardiac, GI, hepatic, and renal conditions, as well as anyone who has recently undergone cardiac bypass graft surgery. The product contains NSAIDs as well, which could lead to an overdose in those who are already taking that over-the-counter pain reliever. NSAID overdose can lead to heart attack, stroke, congestive heart failure, renal toxicity, … [Read more...]

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...]

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