The U.S. Food and Drug Administration today approved Brintellix (vortioxetine) to treat adults with major depressive disorder.
Big Blue Fisheries, Llc Recalls All Smoked Products From All Lots, Various Sizes, in Vacuum Packaging Because of Possible Health Risk
Big Blue Fisheries is recalling ALL smoked products from all lots and codes, various sizes, in vacuum packages because the products may not have been properly cooked and have the potential to be contaminated with Clostridium botulinum, a bacterium which can cause life-threatening illness or death. Consumers are warned not to use the product even if it does not look or smell spoiled.
Carefusion Provides Update On Voluntary Recall Of Avea® Ventilator
CareFusion issued the following update regarding its previously announced voluntary recall of AVEA® ventilators. The company initiated the voluntary recall on Sept. 3, 2013.
Haute Health, LLC Conducts Voluntary Nationwide Recall of All Lots Of Virilis Pro, PHUK And Prolifta Capsules Due To Undeclared Ingredients
Haute Health, LLC is voluntarily recalling all lots of Virilis Pro, PHUK and Prolifta at the retail and consumer level. Virilis Pro, PHUK and Prolifta have been found to contain amounts of the PDE-5 Inhibitor sildenafil, which is an active ingredient in an FDA-approved drug for erectile dysfunction (ED).
Afikim Electric Vehicles Issues Nationwide Recall of Breeze C Scooter
On September 27, 2013, Afikim Electric Vehicles initiated a nationwide recall of 69 Breeze C Scooters. The Breeze C Scooter may become unresponsive during operation due to an electrical contact which may fault due to extensive wear, which potentially could result in the driver not being able to stop the scooter during operation except by turning off the ignition key.
FDA approves Perjeta for neoadjuvant breast cancer treatment
The U.S. Food and Drug Administration today granted accelerated approval to Perjeta (pertuzumab) as part of a complete treatment regimen for patients with early stage breast cancer before surgery (neoadjuvant setting). Perjeta is the first FDA-approved drug for the neoadjuvant treatment of breast cancer.
Safeway Recalls Several Varieties of Angel Food Cake Due to Undeclared Soy and Milk Allergens
Safeway is voluntarily recalling six (6) Angel Food Cake products because they contain the undeclared allergens soy and milk. People who have an allergy or severe sensitivity to soy or milk run the risk of a serious or life-threatening allergic reaction if they consume these products.
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FDA awards seven grants to stimulate development of pediatric medical devices
The U.S. Food and Drug Administration today announced it has awarded seven grants totaling more than $3.5 million to various pediatric device consortia to boost the development and availability of medical devices for children.
W.S. Badger Company Voluntarily Recalls Select Lots of Daily SPF 30 Kids & Baby Sunscreen Lotions Due to Microbial Contamination
W.S. Badger Co. Inc. today announced it is voluntarily recalling all lots of its 4-ounce SPF 30 Baby Sunscreen Lotion and one lot of its 4-ounce SPF 30 Kids Sunscreen Lotion
Garden Fresh Foods, Inc. Expanded Recalls on Specific Packages of Products Because of Possible Health Risk
Garden-Fresh Foods is initiating an expansion to our voluntary recall on various ready-to-eat salads, slaw, and dip products sold under various brands and code dates (see attachment). The products may be contaminated with Listeria monocytogenes, an organism that can cause serious and sometimes-fatal infections in young children, frail or elderly people, and others with weakened immune systems.