November 24, 2020

Search Results for: dietary supplement recall

Indian Herb Dietary Supplement Recalled For Possible Danger

Felt, OK, McDaniel Life-Line LLC is recalling all lots of Indian Herb b because it is marketed without an approved NDA/ANDA (new drug application/abbreviated new drug application). The recall statement says, "The therapeutic claims made in the labeling for this product establish that it is a drug because it is an article (other than food) intended to affect the structure or any function of the body.  Additionally, the product contains ingredients that the Agency has determined to be caustic in nature that can cause serious injury. "Use of the product could result in temporary or permanent damage or loss of body function or structure.  To date, McDaniel Life-Line LLC has received a report of one adverse injury." An NDA helps the FDA decide "whether the drug is safe and effective in … [Read more...]

Zero Xtreme Dietary Supplement Recalled for Sibrutramine

Fat Burners Zone is recalling one lot of Zero Xtreme capsules, a dietary supplement intended for weight loss, because it is contaminated with sibutramine, according to FDA analysis. Sibutramine is an appetite suppressant that was withdrawn from the U.S. market for safety concerns. That means Zero Xtreme is an unapproved drug. Sibutramine is the active ingredient in Meridia, a drug that was marketed in the 1990s for prescription treatment of obesity. It was withdrawing 2010 after clinical dates indicated "Sibutramine poses an increased risk of heart attack and stroke." The product can substantially increase blood pressure and pulse rate, and can present a health risk for anyone with a history of coronary artery daisies, congestive heart failure, arrhythmias, and stroke. No adverse events … [Read more...]

Xanthium & Siler Dietary Supplement Recalled for Banned Substance

Kingsway Trading Inc. is recalling Xanthium & Siler Combo (Bi Yan Pian) Dietary Supplement because it contains banned ephedra alkaloids.  This compound can cause heart attack, stroke, and death. The recall notice states, "these risks are unreasonable in light of any benefits that may result from the use of these products under their labeled conditions of use, or under ordinary conditions of use if the labeling is silent." The product was distributed to Massachusetts, New Jersey, New York, Illinois, Maryland, Florida, Missouri, Texas, Indiana, Georgia, Delaware, Colorado, Virginia, Pennsylvania, Connecticut, Oregon, Virginia, and Arizona through oriental herb stores, acupuncture clinics, and Oriental supermarkets. No illnesses have been reported to date. The recalled product is … [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...]

LGD-Xtreme Dietary Supplement Recalled for Unapproved Drug

Invisiblu International LLC is voluntarily recalling one lot of Continuum Labs LGD-Xtreme because it contains LGD-4033 Ligandrol. The risks of this product are unknown. There have been no reports of adverse events related to the consumption of this product. LGD-Xtreme is marketed as a dietary supplement to promote gains of lean muscle mass. The recalled product is in 3 mg tablets. The product is packaged in a dark amber plastic bottle with ninety capsules. The lot numbers are 21511166 with an expiration date of 11/2018. The product is identified by its black label with gold trim and the Continuum Labs logo. It was sold to consumers in the United States over the internet, and was exported to wholesalers in Brazil. If you purchased this product, stop using it immediately and throw away … [Read more...]

Pink Bikini Dietary Supplement Recalled for Unapproved Drug

Lucy's Weight Loss System is voluntarily recalling all lots of Pink Bikini White powder Capsules because it tested positive for diclofenac after FDA sampling. This is a non steroidal anti-inflammatory drug (NSAID), which can increase the risk of fatal heart attack or stroke if you take high doses of it or take it long term, or if you have heart disease. If pregnant women take this drug during the last three months of pregnancy, it can harm the fetus. That makes this supplement an unapproved new drug. No reports of adverse events have been received to date. The product is packaged in clear bottles with white powder capsules. Each bottle has 30 capsules with 750 mg per capsule. The expiration date of the recalled product is 7/30/2017. It was distributed nationwide via … [Read more...]

Natureal Dietary Supplement Recalled for Unapproved Drugs

Inaffit, LLC is voluntarily recalling all lots of Natureal light green and dark green capsules after FDA testing discovered it contains sibutramine. That is an appetite suppressant that was withdrawn from the U.S. in October 2010. The drug substantially increases blood pressure and/or heart rate in some patients and may present a significant risk for patients who have a history of coronary artery disease, congestive heart failure, arrhythmias or stroke. That makes this supplement an unapproved new drug. It may interact with other medications a consumer is taking in life-threatening ways. The recalled product is used as a weight loss dietary supplement. It is packaged in clear bottles with light green and dark green capsules. The codes on the product are Manufactured 3/12/2015 Expiration … [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...]

Black Ant Dietary Supplement Recalled Again

Eugene oregon, Inc. of Pennsylvania is recalling some dietary supplements because they FDA analysis found they include undeclared amounts of active pharmaceutical ingredients. Those ingredients - sildenafil and tadalafil - can interact with nitrates found in prescription drugs and may lower blood pressure to dangerous levels in some people. No reports of adverse events have been received to date. This is a revised version of the May 5, 2014 recall and includes all lots of the products. The products are African Black Ant, all lot numbers. The packaging is red, black, and silver and there are 6 capsules per box, 8 boxes per display unit. Also recalled is Black Ant, all lot numbers, in green packaging. There are 4 capsules per small box, 20 boxes per display unit. They are also packaged in … [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...]

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