The U.S. Food and Drug Administration today permitted the marketing of PneumoLiner, the first tissue containment system for use with certain laparoscopic power morcellators to isolate uterine tissue that is not suspected to contain cancer. Although the device is an effective tissue containment system, the FDA is requiring the manufacturer to warn patients and health care providers that PneumoLiner has not been proven to reduce the risk of spreading cancer during these procedures.
Granna’s LLC Issues Allergy Alert On Undeclared Milk in French Toast
Granna’s LLC is voluntarily recalling packages of item number 808 French Toast that may contain an undeclared milk allergen. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume this product.
FDA approves first leadless pacemaker to treat heart rhythm disorders
The U.S. Food and Drug Administration today approved the first pacemaker that does not require the use of wired leads to provide an electrical connection between the pulse-generating device and the heart. While the Micra Transcatheter Pacing System works like other pacemakers to regulate heart rate, the self-contained, inch-long device is implanted directly in the right ventricle chamber of the heart.
FDA approves first leadless pacemaker to treat heart rhythm disorders
The U.S. Food and Drug Administration today approved the first pacemaker that does not require the use of wired leads to provide an electrical connection between the pulse-generating device and the heart. While the Micra Transcatheter Pacing System works like other pacemakers to regulate heart rate, the self-contained, inch-long device is implanted directly in the right ventricle chamber of the heart.
Fresh From Texas Recalls Apple Product Because Of Possible Health Risk
Fresh from Texas of San Antonio, Texas is voluntarily recalling multiple products containing sliced red apples which are identified below because they have the potential to be contaminated with Listeria Monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.
FDA approves Inflectra, a biosimilar to Remicade
The U.S. Food and Drug Administration today approved Inflectra (infliximab-dyyb) for multiple indications. Inflectra is administered by intravenous infusion. This is the second biosimilar approved by the FDA.
FDA approves Inflectra, a biosimilar to Remicade
The U.S. Food and Drug Administration today approved Inflectra (infliximab-dyyb) for multiple indications. Inflectra is administered by intravenous infusion. This is the second biosimilar approved by the FDA.
INVISIBLU International LLC Issues Voluntary Nationwide Recall Of Continuum Labs Lgd-4033 Due To Product Containing LGD-4033 (Ligandrol), An Investigational Drug Not Approved For Use
nvisiblu International LLC is voluntarily recalling one lot of Continuum Labs LGD-Xtreme, 3 mg to the retail and consumer level. The product has been found to contain LGD-4033 Ligandrol.
FDA releases final rule to ensure food safety during transport
The U.S. Food and Drug Administration today finalized a new food safety rule under the landmark FDA Food Safety Modernization Act (FSMA) that will help to prevent food contamination during transportation. The rule will require those involved in transporting human and animal food by motor or rail vehicle to follow recognized best practices for sanitary transportation, such as properly refrigerating food, adequately cleaning vehicles between loads and properly protecting food during transportation.
Snyder’s-Lance Announces Voluntary Recall of a Limited Number of Emerald® Cashew Roasted & Salted Halves & Pieces Due to Potential Presence of Glass
Snyder’s-Lance, Inc. is initiating a voluntary recall for a limited amount of Emerald 100 Calorie Pack Roasted & Salted Cashew Halves & Pieces product, distributed nationwide, due to the possible presence of small glass pieces. This voluntary recall covers only specific production codes of the following product: Emerald 100 Calorie Pack Roasted & Salted Cashew Halves & Pieces 7 Packs / 0.62oz