December 5, 2016

Body Shot Bar Step 2 Recalled for Undeclared Drugs

The Body Shot Bar is recalling all lots of Step 2 60 gold capsules because it contains sibutramine, an appetite suppressant, that was withdrawn from the U.S. market in 2010, along with phenolphthalein, a laxative. No complaints or reports of adverse effects have been received to date. Sibutramine will substantially increase blood pressure and/or pulse rate in some patients and can present a significant risk for patients who have a history of coronary artery disease, heart failure, arrhythmias, or stroke. It also contains phenolphthalein, an ingredient used in over the counter laxatives that was removed from the market because of carcinogen concerns. These ingredients could also interact in life-threatening ways with other medications people may be taking. The product is sold as a … [Read more...]

Black Gold X Advanced, Other Supplements Recalled

Making It A Lifestyle is recalling all lots of 3rd Degree, Black Gold X Advanced and Black Label X capsule because they contain undeclared sibutramine and sildenafil. Those ingredients make these products an unapproved new drug. No adverse events have been reported to date. Sibutramine is in 3rd Degree and Black Gold X Advanced. This is a controlled substance that was removed from the market in 2010 because it substantially increases blood pressure and/or pulse rate in some patients and could pose a risk for anyone with heart disease or a history of stroke, congestive heart failure, or arrhythmia. This product can also interact, in life-threatening ways, with any other medications. Black Label X contains sildenafil, the active ingredient in the prescription drug Viagra. This … [Read more...]

Super Herbs Supplement Recalled for Undeclared Drugs

Super Herbs is recalling all bottles of Super Herbs, light green and dark green capsules after FDA testing found that the products contain sibutramine, desmethylsibutramine, and/or phenolphthalein.There have been no reports of adverse events received to date. Sibutramine is an appetite suppressant that was taken off the 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 used in over-the-counter laxatives, but because of concerns of carcinogenicity, it cannot be sold in the U.S. These … [Read more...]

Bee Extremely Amazed Recalls Weight Loss Supplements

Bee Extremely Amazed LLC of Ohio is voluntarily recalling dietary supplements marketed for weight loss because the contain undeclared drug ingredients. Those drugs are sibutramine and/or phenolphthalein. Sibutramine is an appetite suppressant withdrawn from the U.S. market in 2010 since it can substantially increase blood pressure and/or pulse rate in some patient and may present a significant risk for anyone with a history of heart problems. Phenolphthalein is an ingredient used over-the-counter laxatives, but it is not approved for use in the U.S. because of concerns that it could cause cancer and could cause serious GI disturbances and irregular heartbeat. You can see the long list of recalled items, along with package sizes at the FDA web site. The recalled products are Asset … [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...]

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...]

Akttive Fat Burner Recalled for Unapproved Drugs

Life & More, L.L.C.  of Miami is voluntarily recalling 783 bottles of  Akttive High Performance Fat Burner Gold that were found to contain undeclared, unapproved drugs.  Consumers who have purchased this product with the lot #000185004400, UPC 859189005005, and Expiration 12/17 should not use it as serious health problems could occur if they do. The US Food and Drug Administration (FDA) tested the product and found that it contained Sibutramine, desmethylsibutramine, and Phenolphthalein.  According to the FDA, "Sibutramine is an appetite suppressant that was withdrawn from the U.S. market in October 2010 (due to increased risk of seizures, heart attacks, arrhythmia and strokes). Phenolphthalein is an ingredient previously used in over-the-counter laxatives, but because of concerns … [Read more...]

G&C Natural Nutrition Recalls Pyrola for Undeclared Drugs

G&C Natural Nutrition of California is recalling all lots of Pyrola, Advanced Joint Formula capsules because they may contain diclofenac and chlorpheniramine, which makes this product an undeclared drug. No reports of illness or adverse reactions have been received to date. Diclofenac is a non-steroidal anti-inflammatory drug (NSAID), which may cause increased risk of heart attack and stroke as well as stomach bleeding, ulceration, and fatal perforation of the stomach and intestines. Chlorpheniramine is an over the counter antihistamine used for allergies. The recalled product is Pyrola 430 mg/capsule Advanced Joint Formula. It is packaged in a white bottle. The product was sold to distributors and consumers nationwide through phone orders and online from April 2013 through June … [Read more...]

Ultra Zx Recalled for Undeclared Drugs

Ultra Zx Labs is recalling UltraZx weight loss supplements because it contains undeclared Sibutramine and phenolphthalein. Sibutramine is a controlled substance that was removed from the market in 2010 because it substantially increases blood pressure and can be a "significant risk" for patients with a history of heart disease or stroke. Phenolphthalein is not approved as a supplement or a drug because it causes cancer. No reports of adverse events have been received to date. UltraZx weight loss supplement is marketed as a dietary supplement and is packaged in bottles of 30 capsules of 300 mg each. This recall includes all lots/bottles/packages. They were sold from September 2014 until February 2015. Do not take this supplement. If you have purchased it, return to the place of … [Read more...]

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