Real Foods in Kent, WA is initiating a voluntary recall of 356 cases (712 units) of Small Heart Strawberry Tray with Devonshire Dip, due to misbranding and undeclared allergens. The company was alerted to the issue by a retail operation selling the product, that the strawberry trays were incorrectly packaged with Buttermilk Ranch Dressing in […]
Hines Nut Company, Dallas, TX, today announced a voluntary recall of WALNUT HALVES & PIECES, Lot Number 6908. The product was sold by GOLD STATE NUT COMPANY of Biggs, CA, and packaged by Hines Nut Company. Read The Complete Story!
Hines Nut Company, Dallas, TX, today announced a voluntary recall of WALNUT HALVES & PIECES, Lot Number 6908. The product was sold by GOLD STATE NUT COMPANY of Biggs, CA, and packaged by Hines Nut Company. Read The Complete Story!
The U.S. Food and Drug Administration today cleared for marketing the ENROUTE Transcarotid Neuroprotection System (ENROUTE TNS), for use during a minimally invasive procedure to restore normal blood flow to narrowed carotid arteries. It is the first device designed to access the carotid arteries through an incision in the neck, instead of the groin, and […]
The U.S. Food and Drug Administration today expanded the approved use for Lucentis (ranibizumab injection) 0.3 mg to treat diabetic retinopathy (DR) in patients with diabetic macular edema (DME).
Middle East Bakery, Inc. of Lawrence, Massachusetts is recalling select lots of bread products bearing the Joseph’s and Trader Joe’s brand names because they may contain undeclared soy. People who have an allergy or severe sensitivity to soy run the risk of serious or life-threatening allergic reaction if they consume these products. Read The Complete […]
A federal judge from the U.S. District Court for the District of New Hampshire has entered a consent decree of permanent injunction against Maquet Holding B.V. & Co. KG (Maquet), and two of the company’s officers, Heinz Jacqui and Gail Christie, for repeatedly failing to correct violations at three of its companies, which are also […]
The U.S. Food and Drug Administration (FDA) today approved TissuGlu, the first tissue adhesive approved for internal use.
The U.S. Food and Drug Administration today granted accelerated approval to Ibrance (palbociclib) to treat advanced (metastatic) breast cancer.
The U.S. Food and Drug Administration is requesting a budget of $4.9 billion to protect and promote the public health as part of the President’s fiscal year (FY) 2016 budget – a nine percent increase over the enacted budget for FY 2015. The overall request includes $147.7 million in budget authority for initiatives tied to […]
The U.S. Food and Drug Administration today expanded the approved uses of Vyvanse (lisdexamfetamine dimesylate) to treat binge-eating disorder in adults. The drug is the first FDA-approved medication to treat this condition.
At the request of the U.S. Food and Drug Administration, a federal judge from the U.S. District Court for the Central District of California today entered a consent decree of permanent injunction against Laclede, Inc. of Rancho Dominguez, California, and its president, Michael A. Pellico. Laclede is the manufacturer of Luvena Prebiotic products.
Freeland Foods, Inc. of San Jose, CA is voluntarily recalling the Go Raw Organic Sunflower Seed, UPC number 8 59888 00009 7 with lot number “Enjoy before August 22, 2015 R5,” because it has the potential to be contaminated with Salmonella, an organism which can cause serious infections in young children, frail or elderly people, […]
REO Spice & Seasoning, INC Huntsville, TX is recalling certain REO Country Style Chili Seasoning packages after learning that one ingredient purchased from a supplier may contain peanut protein allergens that are not declared on the products’ ingredient statements. People who have an allergy or severe sensitivity to peanuts run the risk of serious or life […]
The U.S. Food and Drug Administration today expanded the approved use of Imbruvica (ibrutinib) for previously treated patients with Waldenström’s macroglobulinemia (WM), a rare form of cancer that begins in the body’s immune system. The drug received a breakthrough therapy designation for this use.
The U.S. Food and Drug Administration announced today that it will strengthen its review of automated external defibrillators (AEDs) to help improve the quality and reliability of these devices.
Elevated Ice Cream Co. advises our customers that our dairy, Snoqualmie Gourmet Ice Cream Dairy in Maltby, has issued a voluntary recall of all dairy products processed in their plant. Elevated Ice Cream uses dairy products processed by Snoqualmie Gourmet, therefore we are asking all of our customers not to eat any ice cream which […]
Lime Green Grocer, Inc. of Seattle, Washington is recalling 783 individually wrapped Thai Delight Burritos, because it may contain undeclared soy. People who have an allergy or severe sensitivity to soy run the risk of serious or life-threatening allergic reaction if they consume this product. Read The Complete Story!
The U.S. Food and Drug Administration today approved the first generic version of Nexium (esomeprazole magnesium delayed-release capsules) to treat gastroesophageal reflux disease (GERD) in adults and children ages 1 and older. Esomeprazole is a proton pump inhibitor that reduces the amount of acid in the stomach.