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.
FDA approval expands access to artificial heart valve for inoperable patients
The U.S. Food and Drug Administration today approved revised labeling for the Sapien Transcatheter Heart Valve (THV), making the device available to an expanded group of patients who have inoperable aortic valve stenosis, a disease of the heart valves that causes narrowing of the aortic valve, restricting blood flow from the heart.
FDA issues final guidance on mobile medical apps
Today, the U.S. Food and Drug Administration issued final guidance for developers of mobile medical applications, or apps, which are software programs that run on mobile communication devices and perform the same functions as traditional medical devices. The guidance outlines the FDA’s tailored approach to mobile apps.
U.S. Marshals seize food products at two Virginia food companies
U.S. Marshals seized food products at Gourmet Provisions, LLC and Royal Cup, Inc., after U.S. Food and Drug Administration investigators found widespread and active rodent and insect infestation on the premises.
FDA finalizes new system to identify medical devices
Today, the U.S. Food and Drug Administration announced a final rule for the unique device identification system (UDI) that, once implemented, will provide a consistent way to identify medical devices.