December 7, 2016

Terra-Medica Recalls Drug Product for Undeclared Penicillin

Terra-Medica is recalling 56 lots of homoepathic drug products because they may have the drug penicillin that is not declared on the label. Anyone who is allergic to penicillin, or allergic to beta-lactam antibiotics, even at low levels, could have a serious or life-threatening anaphylactic reaction if they consume these products. The penicillin or derivatives of penicillin could be produced during the fermentation process. No reports of adverse reactions have been reported to date. The recalled products are Pleo-FORT, Pleo-QUENT, Pleo-NOT, Pleo-STOLO, Pleo-NOTA-QUENT, and Pleo-EX homeopathic drug products, in liquid, tablet, capsules, ointment, and suppository forms. The products have a label stating "Distributed by SANUM USA Corp." The expiration dates range from March 2014 through … [Read more...]

US Marshals Seize Dietary Supplements from Globe All Wellness LLC

U.S. Marshalls, acting on behalf of the FDA, seized tainted dietary supplements from Globe All Wellness LLC in Hollywood, Florida. The products contain an undisclosed active pharmaceutical ingredient. The products allegedly contain sibutramine hydrochloride (sibutramine), which is the active ingredient in the obesity drug Meridia. Meridia was withdrawn from the market in December 2010 after clinical data showed it increased the risk of heart attack and stroke. Howard Sklamberg, director of the Office of Compliance in the FDA's Center for Drug Evaluation and Research said, "companies that distribute products containing undisclosed drugs are not only breaking the law, they are putting consumers at risk. With these kinds of hidden dangers,  consumers cannot make informed decisions about … [Read more...]

Court Shuts Down Operations of Titan Medical Enterprises

A federal judge has ordered Titan Medical Enterprises of Santa Fe Springs, California to shut down in response to a complaint filed by the U.S. Justice Department, on behalf of the FDA. The facility must stop manufacturing and distributing drugs and dietary supplements until their operations comply with the Federal Food, Drug, and Cosmetic Act. The court found that the company "failed to follow current Good Manufacturing Practice for drugs and for dietary supplements (Dietary Supplement cGMP). Unapproved new drugs were used in the supplements in violation of the Act. Associate Commissioner for Regulatory Affairs Melinda K. Plaisier said, "the FDA continues to take strong enforcement actions against companies that fail to comply with federal drug and dietary supplement manufacturing … [Read more...]

Rugby Natural Iron Supplements Recalled

Advance Pharmaceutical Inc. is recalling Rugby Natural Iron Supplement, in the form of ferrous sulfate tablets because they may contain Meclizine HCl tablets. Meclizine toxicity may lead to impaired alertness, drowsiness, confusion, low blood pressure, coma, and respiratory depression. This toxicity can be life-threatening. The tablets are 325 mg, lot 12G468. The expiration date is 07/14. The lot was manufactured and packaged in 100 count bottles. Taking Meclizine HCl 25 mg as Ferrous Sulfate 325 mg may cause serious side effects to those who consume alcohol or other sedatives, those with a pre-existing CNS disorder, those with impaired kidney or liver function, the elderly, nursing infants of mothers who took the drug, and newborns of mothers who received the drug immediately before … [Read more...]

Dangerous Supplement Now Sold as “WOW”

The Food and Drug Administration (FDA) is warning the public that a product distributed and sold under the name "WOW" is another banned product in disguise. Earlier this year, the FDA warned the public about taking Reumofan Plus, which was marketed as a "natural" dietary supplement for the treatment of arthritis and bone cancer. It contained undeclared active ingredients found in prescription drugs that should be used only under the supervision of a health care professional. Apparently, some distributors have deliberately put a new label and new name, WOW, on bottles of Reumofan Plus to deceptively sell remaining supplies. It was distributed to online retailers and other distributors, as well as directly to consumers. Since June, the FDA has received dozens of reports of serious and … [Read more...]

Slimdia Revolution Dietary Supplements Recalled

P&J Trading is recalling dietary supplements sold under the brand name SLIMDIA REVOLUTION because FDA testing found that the products contain Sibutramine. That compound is an appetite suppressant that was FDA-approved for the treatment of obesity. It is a Schedule IV controlled substance and should only be taken under the direct supervision of a health care professional. Sibutramine can substantially increase blood pressure and/or pulse rate in some people and may present a risk to some patients. It has been withdrawn from U.S. markets. The recalled product is sold in bottles containing 30 capsules. There is no identifying lot number. It was distributed throughout the United States from March 2012 to December 2012. If you have purchased this product, do not consume it. Return any … [Read more...]

Performance Plus Marketing Recalling Supplements for Unapproved New Drugs

Performance Plus Marketing is recalling Libigrow®, Libigrow XXXtreme®, Blue Diamond®, Blue Diamond Platinum®, Mojo Nights®, Mojo Nights Supreme®, and Casanova® because they contain undeclared Sulfoaildenafil and Thioaildenafil. Those are analogues of sildenafil, which is an FDA-approved drug for the treatment of male Erectile Dysfunction. That makes the recalled products unapproved new drugs. You can see all of the product names, UPC codes, packaging types, lot numbers, and expiration dates at the FDA web site. The unapproved drugs are close in nature to sildenafil and are a threat to some consumers. The drugs may interact with nitrates found in some prescription drugs and may lower blood pressure to dangerous levels. The recall includes ALL authentic lot numbers and known to be … [Read more...]

LifeVantage Recalls Protandim Dietary Supplements for Foreign Materials

LifeVantage Corporation is recalling select lots of Protandim®, the Nrf2 Synergizer® dietary supplement because there may be small metal fragments in the final product. The fragments were discovered in batches of turmeric extract, an ingredient that came from a third party supplier. The supplement is packaged in a cylindrical blue bottle, with 30 caplets per bottle. You can see the lot numbers and expiration dates at the FDA web site. The supplements were distributed in the United States and Japan between July and November 2012. After consulting with doctors, the company believes there is no serious risk to consumer health. There have been no reports of illness or injury associated with the consumption of this product. If you have purchased this product, stop taking it. For … [Read more...]

Zi Xiu Tang Success Recalls Capsules for Unapproved New Drugs

Zi Xiu Tang Success LLC is recalling four lots of Classic Xi Xiu Tang Bee Pollen Capsules and three lots of Ultimate Formula Capsules because they contain undeclared Sibutramine. This is a previously controlled substance that was removed from the U.S. market in October 2010 for food safety reasons. This drug increases blood pressure and/or pulse rate in some patients and may present a significant health risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke. The Bee Pollen product is marketed as a dietary supplement used as a weight loss aid. It is packaged in bottles of 60 capsules. The UPC number is 6937000700019 with lot numbers 04/15/2012, 05/15/2012, 06/15/2012 and 07/15/2012. It was distributed from May 1 to October 17, 2012 … [Read more...]

EphBurn Dietary Supplement Recalled for Ephedrine Alkaloids

Brand new Energy re-sale distributor is recalling all lot codes of EphBurn 25. The FDA has notified them that one lot of EphBurn 25 was sampled and found to contain ephedrine alkaloids, making it an unapproved drug. Ephedrine is a stimulant, appetite suppressant, concentration aid, and decongestant. Adverse effects of this drug include elevated blood pressure, rapid heartbeat, nerve damage, muscle injury, psychosis, and memory loss. More serious side effects include heart attack, stroke, seizure, and death. But there have been no reports of adverse events associated with the consumption of this product. The recall affects all lot codes and use-by dates of EphBurn 25. The product is a 90-count bottle with red capsules. It displays the product name "ephBURN 25" in white letters on a … [Read more...]

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