Giant Food, LLC announced it removed from sale Giant Brand Frozen Whole Kernel Sweet Corn due to potential Listeria monocytogenes contamination. Read The Complete Story!
The Stop & Shop Supermarket Company LLC announced it removed from sale Stop & Shop Brand Frozen Whole Kernel Sweet Corn due to potential Listeria monocytogenes contamination. Read The Complete Story!
Commissioner statement on FDA’s comprehensive regenerative medicine policy framework to spur innovation, efficient access to potentially transformative products, while ensuring safety and efficacy
FDA announces comprehensive regenerative medicine policy framework to spur innovation, efficient access to potentially transformative products, while ensuring safety and efficacy.
Casa Sanchez Foods of Hayward, CA, is recalling its 9-ounce containers of “Real Guacamole” 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. Although healthy individuals may suffer only short-term […]
Yorgo’s Foods Inc. of Manchester NH, a family-owned company, started in 1993, is recalling all Greek-style food products it manufactures, out of an abundance of caution, as they have the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in pregnant women, young children, frail or elderly […]
Newly authorized test detects genetic cancer mutations in 468 unique genes
FDA approves treatment for rare genetic enzyme disorder
FDA permits marketing of the first device for use in helping to reduce the symptoms of opioid withdrawal
Baxter International Inc. announced today it is voluntarily recalling one lot of NEXTERONE (amiodarone HCl) 150 mg/100 mL Premixed Injection – distributed between 6/23/2017 and 10/2/2017 in the United States to wholesalers/distributors and healthcare facilities – due to the potential presence of particulate matter. The particulate matter may have entered the solution during the manufacturing […]
A botanical substance known as kratom has raised significant concerns given its increasing prevalence and potential safety risks. The FDA has issued a public health advisory related to mounting concerns regarding risks associated with the use of kratom.
The U.S. Food and Drug Administration today approved the first drug in the U.S. with a digital ingestion tracking system. Abilify MyCite (aripiprazole tablets with sensor) has an ingestible sensor embedded in the pill that records that the medication was taken. The product is approved for the treatment of schizophrenia, acute treatment of manic and […]
Seattle Gourmet Foods of Kent, Washington is recalling 127 cases of Costco item # 2335, Dilettante Chocolates Espresso Blend, Espresso Beans in Semisweet, Milk and White Chocolate, because it may contain undeclared almonds. People who have an allergy or severe sensitivity to almonds run the risk of serious or life-threatening allergic reaction if they consume […]
Nestlé USA has initiated a recall of Hot Pockets® Four Cheese Pizza Snack Bites due to misbranding and undeclared allergens. The product was donated to a charitable organization in Missouri and was not sold in retail. The product contain the known allergens egg, milk, soy, and wheat, which are not declared. People who have an […]
Yorgo Foods Inc of Manchester NH, is recalling select varieties of Hommus and Baba Ghannouj, 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. Although healthy individuals may suffer only […]
Figi’s Companies, Inc of Marshfield, WI is recalling the following 2 products that are related to the GKI FOODS LLC Dark Chocolate Products recall because it may contain 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 these […]
Germack Roasting Co, is recalling its 5 ounce and 1lb packages of Germack Dark Chocolate Almond Bark because they may contain undeclared milk. People who have allergies to milk run the risk of serious or life-threatening allergic reaction if they consume these products. Read The Complete Story!
Kroger stores in Michigan are recalling select bulk dark chocolate products following the GKI Foods LLC recall of dark chocolate products due to an undeclared milk allergen. People who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they consume this product.
To further streamline the submission and review process for shared system REMS (for any REMS that includes more than one medication), today the FDA is releasing a draft guidance for industry, Use of a Drug Master File for Shared System REMS Submissions, that describes how applicants can submit collective sets of files to the FDA […]