The U.S. Food and Drug Administration (FDA) today announced that Scientific Laboratories Inc., and its president, Rajeshwari Patel, and chief executive officer, Amit Roy, have signed a Consent Decree of Permanent Injunction and are barred from manufacturing and distributing drug products until they bring their manufacturing operations into compliance with law and obtain approval for their products.

The U.S. Food and Drug Administration today announced the shut down of cream cheese and seafood operations at Lifeway Foods, Inc. and its subsidiary, LFI Enterprises, Inc., both Illinois companies, until they are found compliant with food-safety laws.

The HeartMate II LVAS is a left ventricular assist device (LVAD) system; a device that helps the heart?s left ventricle (the main pumping chamber of the heart) deliver blood to the rest of the body. The HeartMate II LVAS includes...

The U.S. Food and Drug Administration's final analysis of certain flavors of "Total Body Formula" and "Total Body Mega Formula" has detected hazardous amounts of chromium.

FDA recently licensed a new treatment for hemophilia A called Xyntha. Xyntha, which is made by Wyeth Pharmaceuticals, is a genetically engineered version of factor VIII, a protein essential for blood clotting that is decreased or absent in patients ...

FDA is cautioning healthcare professionals, patients and caregivers about the unsafe use of Tussionex Pennkinetic Extended-Release Suspension. This product is a long-acting cough suppressant containing hydrocodone, a narcotic antitussive, and chlorp...

Biogen Idec and Elan Pharmaceuticals are warning healthcare professionals about reports of clinically significant liver injury in patients taking Tysabri (natalizumab). Tysabri is a monoclonal antibody used to treat certain patients with relapsing f...

Roche Laboratories has updated information on neuropsychiatric events for Tamiflu (oseltamivir phosphate), a drug that's used to treat or prevent influenza in patients 1 year and older. The revised labeling reminds practitioners that some patients...

Talecris Biotherapeutics has revised the directions for administering some of the company's immune globulin products -- ones that come in uncalibrated prefilled 2 mL syringes with fixed needles. The products are HyperRAB™ S/D , which is an anti-rabi...

FDA and Tibotec Therapeutics are alerting healthcare professionals about the risk of hepatotoxicity associated with the antiretroviral drug Prezista (darunavir). Prezista, co-administered with ritonavir and other antiretroviral agents, is used to tr...

In a recent Public Health Notification, FDA informed healthcare professionals about new data on mortality rates associated with the AneuRx® Stent Graft System. This endovascular graft, made by Medtronic, is used as an alternative to open surgery in ...

FDA has issued an advisory about the danger of mistakenly swallowing Spiriva (tiotropium bromide inhalation powder) and Foradil (formoterol fumarate inhalation powder) inhalation capsules. These capsules are intended to be used with inhalation devic...

FDA is aware of cases where patients have used LifeScan OneTouch Ultra test strips with their Abbott Precision Xtra blood glucose meters. As a result, the meters recorded lower-than-expected blood glucose levels, which can have serious clinical ...

The Health and Diet Survey: Dietary Guidelines Supplement tracks national change of Americans' attitudes, awareness, knowledge, and behavior regarding various elements of nutrition and physical activity.

FDA is announcing the withdrawal of a guidance document entitled "FDA Recommendations for Sampling and Testing Yellow Corn and Dry-Milled Yellow Corn Shipments Intended for Human Food Use for Cry9C Protein Residues"

The Talent™ Abdominal Stent Graft System is used to repair aneurysms of the aorta in the abdomen (belly). An aneurysm is a diseased, weakened and bulging section of an artery wall. The Talent™ Abdominal Stent Graft System is made of a fabric...

FDA announced that at least 23 people in 14 states have been diagnosed with salmonellosis that was caused by the same strain of Salmonella that was found in the recently recalled unsweetened Puffed Rice and unsweetened Puffed Wheat cereals produced by Malt-O-Meal.

The CONTAK RENEWAL® 3 AVT CRT-D® is an implantable cardioverter defibrillator (ICD) that also delivers cardiac resynchronization therapy (CRT) and atrial therapies.

FDA announced it has found hazardous levels of selenium in samples of certain flavors of the dietary supplements products Total Body Formula and Total Body Mega Formula. The FDA has received 43 reports of persons from nine states who experienced serious reactions using these three products.

Federal authorities seize more than 14,000 dosage units of Shangai Regular, Shangai Ultra, Super Shangai, Naturale Super Plus, and Lady Shangai. Although labeled as natural supplements, the seized products were all marketed to treat erectile dysfunction (ED) impotency, and/or to provide sexual enhancement, which caused them to be be drugs under the Federal Food Drug, and Cosmetic Act.