Medtronic Announces FDA Classification Of Deep Brain Stimulation Lead Cap Communication

In keeping with its commitment to keep physicians informed about product performance and safety, Medtronic, Inc. (NYSE: MDT) issued an Urgent Medical Device Correction notification in February 2013 to provide physicians with information concerning the potential for deep brain stimulation (DBS) lead damage associated with the use of the lead cap provided in Medtronic DBS lead kits and dystonia therapy kits.

American Lifestyle Issues a Worldwide Voluntary Recall of Vicerex Capsules and Black Ant Capsules, Marketed as a Dietary Supplement, Due to Undeclared Active Ingredients

May 1, 2013 – American Lifestyle is announcing that it is conducting a voluntary recall of all lots of Vicerex UPC 893490820087 and Black Ant UPC 4026666142546. Laboratory analysis conducted by the FDA has determined the Vicerex product contains undeclared tadalafil and the Black Ant product contains undeclared sildenafil.

FDA approves Plan B One-Step emergency contraceptive without a prescription for women 15 years of age and older

The U.S. Food and Drug Administration today announced that it has approved an amended application submitted by Teva Women’s Health, Inc. to market Plan B One-Step (active ingredient levonorgestrel) for use without a prescription by women 15 years of age and older.

Krinos Foods, LLC. Voluntarily Recalls Tahini Jars Because of Possible Health Risk

Krinos Foods, LLC. of Long Island City, New York is voluntarily recalling its TAHINI sesame paste, because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.

FDA approves Kcentra for the urgent reversal of anticoagulation in adults with major bleeding

The U.S. Food and Drug Administration today approved Kcentra (Prothrombin Complex Concentrate, Human) for the urgent reversal of vitamin K antagonist (VKA) anticoagulation in adults with acute major bleeding. Plasma is the only other product approved for this use in the United States.

Voluntary Nationwide Recall of 15 Lots of Piperacillin and Tazobactam for Injection, USP 40.5 Grams Due to Possibility of Precipitation / Crystallization in IV Bag or IV Line Upon Reconstitution

WESTON, FL, April 26, 2013 /CNW/ – Apotex Corp. announced today that it is conducting, on behalf of the manufacturer Hospira, Inc., a voluntary nationwide recall of 15 lots of Piperacillin and Tazobactam for Injection, USP 40.5 grams, NDC number 60505-0773-00 to the hospital / healthcare provider /user level. The impacted lots of Piperacillin and Tazobactam for Injection, USP 40.5 grams may show precipitation / crystallization in IV bag or IV line after reconstitution.