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.
Category Archives: Food & Drug Recalls
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
Roland Foods, LLC, Initiates A Voluntary Recall Of Roland® Fire Roasted Red Pepper Strips Due To The Possible Presence Of Glass In The Product
Roland Foods, LLC, of New York, NY, in cooperation with the manufacturer in Peru, is initiating a voluntary recall of specific lots of Roland Fire Roasted Red Pepper Strips due to the possible presence of glass fragments in the product, therefore posing a potential health hazard.
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Alimentos Congelados, S.A. Recalls Frozen Broccoli Cuts Because of Possible Health Risk
Alimentos Congelados, S.A. (Pinula) is voluntarily recalling 1,800 cases of Frozen Broccoli Cuts because it has 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. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.
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FDA proposes limit for inorganic arsenic in infant rice cereal
The U.S. Food and Drug Administration is taking steps to reduce inorganic arsenic in infant rice cereal, a leading source of arsenic exposure in infants. Relative to body weight, rice intake for infants, primarily through infant rice cereal, is about three times greater than for adults. Moreover, national intake data show that people consume the most rice (relative to their weight) at approximately 8 months of age.