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 process.
Statement from FDA Commissioner Scott Gottlieb, M.D. on FDA advisory about deadly risks associated with kratom
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.
FDA approves pill with sensor that digitally tracks if patients have ingested their medication
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 mixed episodes associated with bipolar I disorder and for use as an add-on treatment for depression in adults.
Seattle Gourmet Foods Issues Allergy Alert on Undeclared Almonds In 5 Pound Bags of Dilettante Chocolates Espresso Blend
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 this product.
Nestle USA Initiates Voluntary Recall of Hot Pockets® Four Cheese Pizza Snack Bites Due to Undeclared Allergens
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 allergy or severe sensitivity to eggs, milk, soy or wheat run the risk of serious or life-threatening allergic reaction if they consume this product.
Yorgo Foods Inc is Recalling Various Flavors of Hommus Because of Possible Health Risk
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 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.
Figi’s Issues Recall Alert Due to Undeclared Allergen (Milk) in Dark Chocolate Gingersnaps
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 products.
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GKI Issues Allergy Alert On Undeclared Milk In Dark Chocolate Almond Bark
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.
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Kroger Stores Issue Allergy Alert on Dark Chocolate Products due to Undeclared Milk
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.
Statement from FDA Commissioner Scott Gottlieb, M.D. on new steps to improve FDA review of shared Risk Evaluation and Mitigation Strategies to improve generic drug access
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 that represent all participating firms.