FDA permits marketing of first medical device to use artificial intelligence to detect greater than a mild level of diabetic retinopathy in the eye of adults who have diabetes.
Category Archives: Food Safety News
FDA clears first contact lens with light-adaptive technology
FDA clears first contact lens with additive that automatically darkens the lens when exposed to bright light
Stewart’s Shops Issues Allergy Alert on Pint Chocolate Peanut Butter Cup Ice Cream
Stewart’s Shops Corp. is recalling units of Stewart’s pint Chocolate Peanut Butter Cup ice cream because they may have been packaged incorrectly with a “Chocolate” lid. People who have an allergy to peanuts run the risk of serious or life-threatening allergic reaction if they consume this product.
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FDA restricts sale and distribution of Essure to protect women and to require that patients receive risk information
FDA is restricting the sale and distribution of the Essure device to only those health care providers who provide information to women about the risks and benefits of this device before they get the permanent contraception implant.
Bob’s Red Mill Natural Foods, Inc. Voluntarily Recalls Organic Amaranth Flour (22 Oz.) Because of Possible Health Risk
Bob’s Red Mill Natural Foods is voluntarily recalling 2,099 cases of Organic Amaranth Flour (22 oz.), after recent testing revealed the presence of Salmonella in a single LOT of Organic Amaranth Flour (22 oz.) with a Sell By date of Nov. 26, 2015.
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Recall of Certain Lots of Izzy’s Maple Nut Ice Cream Due to Undeclared Peanuts
Izzy’s Ice Cream, LLC is voluntarily recalling limited numbers of its Maple Nut Ice Cream pints following a supplier’s recall of walnuts due to the possible presence of undeclared peanut residue. People who have an allergy or severe sensitivity to peanuts run the risk of serious or life-threatening allergic reaction if they consume these products
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FDA orders mandatory recall for kratom products due to risk of salmonella
Today, the U.S. Food and Drug Administration announced it has issued a mandatory recall order for all food products containing powdered kratom manufactured, processed, packed, or held by Triangle Pharmanaturals LLC, after several were found to contain salmonella. The agency took this action after the company failed to cooperate with the FDA’s request to conduct a voluntary recall. This is the first time the agency has issued a mandatory recall order to protect Americans from contaminated food products.
New York raw milk cheese company ordered to stop sales for food safety violations
FDA announces an enforcement action taken against Vulto Creamery of New York. The company cannot sell ready-to-eat raw cheese product until it complies with the consent decree. Vulto was linked to an outbreak last year.
Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s efforts to enhance the patient perspective and experience in drug development and review
FDA issues update to Benefit-Risk Assessment plan as part of efforts to enhance the patient perspective and experience in drug development and review
FDA expands approval of Blincyto for treatment of a type of leukemia in patients who have a certain risk factor for relapse
FDA expands approval of Blincyto for treatment of a type of leukemia in patients who have a certain risk factor for relapse