The U.S. Food and Drug Administration today issued draft guidance that clarifies when changes or modifications to a previously cleared 510(k) device require a new premarket submission.
Foodborne outbreak potentially associated with papaya distributed by Agromod Produce, Inc.
The FDA is taking steps to protect the public following the identification of Salmonella Agona in Agromod Produce, Inc.’s supply of fresh papayas. The FDA is advising consumers not to eat papayas from Agromod Produce, Inc. The company is voluntarily recalling the product. The papayas were imported from Mexico, and may be linked to the reported cases of Salmonella Agona. Recent sampling by the FDA found the outbreak strain in two papaya samples: one collected at the Agromod Produce, Inc. location in McAllen, Texas, and one collected at the U.S. border destined for Agromod Produce, Inc. The shipments that tested positive with the outbreak strain were not distributed in the U.S.
FDA Center for Drug Evaluation and Research develops strategic science and research agenda
A U.S. Food and Drug Administration report from its Center for Drug Evaluation and Research (CDER), available today in the Federal Register, identifies the current regulatory science needs that will guide CDER’s strategic planning of internal research initiatives and contributions to the development of agency regulatory science efforts.
Agromod Produce, Inc. Recalls Papaya Because Of Possible Health Risk
Agromod Produce, Inc. of McAllen, Texas is recalling all Papayas, because they have 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.
FDA approves blood-thinning drug Brilinta to treat acute coronary syndromes
The U.S. Food and Drug Administration today approved the blood-thinning drug Brilinta (ticagrelor) to reduce cardiovascular death and heart attack in patients with acute coronary syndromes (ACS).
Euphoria Fancy Food Inc. Issues An Alert On Uneviscerated Fish
Euphoria Fancy Food Inc. 149-151 2nd Ave. Brooklyn NY 11215 is recalling Herring Special Salting discovered by New York State Department of Agriculture and Markets Food Inspectors during a routine inspection and subsequent analysis of product by Food Laboratory personnel confirming that the fish was not properly eviscerated prior to processing. This product may be contaminated with Clostridium botulinum spores, which can cause Botulism, a serious and potentially fatal food-borne illness.
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FDA, federal partners develop tools for food-emergency readiness
The U.S. Food and Drug Administration and federal partners today released the Food Related Emergency Exercise Boxed (FREE-B) set, a Web-based collection of scenarios that will help government regulators, public health organizations and the food industry test their readiness for food-related emergencies, such as a human health emergency caused by an unintentional contamination of produce with E. coli O157:H7.
Arizona Canning Company Issues Allergy Alert On Undeclared Soy Protein In Sun VIsta Brand Red Enchilada Sauce
Arizona Canning Company is recalling its 29 ounce cans of Sun Vista Red Enchilada Sauce (Mild, Medium and Hot) because they may contain undeclared soy protein. People, who have allergies to soy, run the risk of serious or life-threatening allergic reaction if they consume these products.
Global Focus Marketing & Distribution, Ltd. Recalls The Silencer® S2200 Centrifuge
Global Focus Marketing &
Distribution, Ltd. is initiating a recall of the Silencer® S2200 model centrifuge due to a reported
incident of a bucket and insert not being seated on the rotor, breaking the lid, and being forced
out of the centrifuge. This could result in serious personal injury and damage to the surrounding
area. Biohazardous materials may be released into the immediate area of the projectiles and
caution should be utilized.
American Regent Initiates Voluntary Nationwide Recall of Calcium Gluconate Injection, USP, 10%, 100 mL Pharmacy Bulk Package Due to Particulates
This voluntary recall was initiated because some of the vials of this lot may contain silicone particles. Potential adverse events after intravenous administration of solutions containing particulates may include disruption of blood flow within small blood vessels in the lung, localized inflammation (swelling and redness due to accumulation of inflammatory cells), and granuloma formation.