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...]
U.S. Marshalls Seize DMAA From Hi-Tech Pharmaceuticals
U.S. Marshals have seized more than $2 million of dietary supplements containing DMAA, an unapproved additive, from Hi-Tech Pharmaceuticals in Norcross, Ga. The supplements were considered adulterated because they contain 1, 3-Dimethylamylamine HCl (DMAA) or its chemical equivalent, which has been deemed unsafe under federal law. More than 1,500 cases of finished goods and more than 1,200 pounds of in-process or raw materials were seized. The U.S. Food and Drug Administration (FDA) has received numerous reports of illnesses and death associated with supplements containing DMAA and urges consumers not to buy or use them. DMAA can elevate blood pressure and cause cardiovascular problems, including heart attack, shortness of breath and tightening of the chest. It can also cause problems … [Read more...]
Vega One Nutritional Supplements Recalled for Antibiotic
Sequel Nationals Inc. dba "Vega" is recalling Vega One Nutritional Shakes and Sports Performance Protein products because they contain trace amounts of chloramphenicol (CAP), a naturally occurring antibiotic. Chloramphenicol is a prescription drug used to treat typhoid fever and eye infections. It should only be used under medical supervision. It can cause aplastic anemia and can cause allergic reactions in some people. Pregnant or lactating women should not take this drug. None of the Vega products include CAP as an ingredient. But an enzyme provided by a third party supplier, which constitutes less than 1% of the product ingredients, had trace amounts of CAP. The products were distributed nationwide in retail stores. There have been no allergic reactions reported associated with the … [Read more...]
OxyElite Pro Supplements Recalled for Links to Liver Illnesses, Death
USPlabs LLC of Texas is recalling some OxyElite Pro dietary supplements products because they have been linked to liver illnesses. The FDA states that there is a "reasonable probability" that the products are adulterated. FDA also said that if the company didn't initiate a voluntary recall, FDA could be law order the company to stop distributing the supplements. This is the second time FDA has exercised its recall authority under the Food Safety Modernization Act of 2011. A warning letter was sent to the company in October 2013. You can see details of the recalled products at the FDA web site. The products include OxyElite Pro Super Thermo capsules, OxyElite Pro Ultra-Intense Thermo capsules, and OxyElite Pro Super Thermo Powder in many sizes. The products are linked to a number of … [Read more...]
Benefiber Recalled for Consumer Complaints
According to the FDA Enforcemnt Report for the week of October 9, 2013, millions of units of Benefiber supplement products are being recalled for a "relatively high number of consumer complaints." The products are manufactured by Novartis Consumer Health. Many of the types and flavors of Benefiber are recalled. To see the large list, along with code info, UPC numbers, names, and distribution, visit the FDA web site. There is no information posted about why these products are being recalled, other than the consumer complaints. Some of the types recalled are Benefiber Fiber Supplement, Benefiber Plus Heart Health Non-Thickening Powder, Benefiber Fiber Drink Mix in Cherry Pomegranate and Kiwi Strawberry flavors, and Benefiber Fiber Supplement Plus Calcium in Orange Natural Flavor. Also … [Read more...]
