The FDA has warned four companies allegedly selling tainted honey products that may be contaminated with hidden active drug ingredients. The four companies are Thirstyrun LLC, also known as US Royal Honey LLC; MKS Enterprise LLC; Shopaxx.com; and 1am USA Incorporated doing business as Pleasure Products USA. The FDA says these products can "post a significant health risk to consumers." Laboratory testing conducted by the FDA found that the product samples contained active drug ingredients that were not listed on the product labels. They were the active drug ingredients found in Cialis (tadalafil) and Viagra (sildenafil), which are FDA approved drugs that are restricted to use under the supervision of a licensed health care professional. Those ingredients can interact with nitrates … [Read more...]
FDA Says Some Weight Loss, Other Supplements May Be Dangerous
The FDA has released a consumer update stating that weight loss products and other supplements, including male enhancement products, that are sold online or in stores may be dangerous because they may be illegal. Some of these dietary supplements can be made with potentially dangerous ingredients that are not listed on the label. Over the past 10 years, the FDA has waned consumers that some products that are sold over the counter contain active hidden ingredients. This is especially the case for products that are marketed for weight loss, pain relief, body building, sleep aids, and male enhancement. Some of these products are actually drugs and are falsely represented as being dietary supplements. FDA has also found products that are marketed as supplements that claim to treat or … [Read more...]
FDA Finds Bitter Orange Supplements Can Contain Unapproved Drugs
The FDA has released a study that finds some bitter orange dietary supplements can contain unapproved drugs. This supplement is sold as a sports performance supplement and weight management supplement. It became popular after Ephedra products, a type of amphetamine, were banned from the U.S. after it was linked to heart attacks, strokes, seizures, and sudden deaths. But as Consumer Reports points out, the government agency hasn't begun enforcement action against the companies that make these products, nor has it warned consumers about them. Manufacturers claim that bitter orange supplements increase energy and suppress appetite. The bitter orange supplements can contain synephrine, an amine, which can cause adverse cardiovascular events, especially when taken with caffeine. For … [Read more...]
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...]
