W.S. Badger Co. Inc. today announced it is voluntarily recalling all lots of its 4-ounce SPF 30 Baby Sunscreen Lotion and one lot of its 4-ounce SPF 30 Kids Sunscreen Lotion
Category Archives: Food & Drug Recalls
Garden Fresh Foods, Inc. Expanded Recalls on Specific Packages of Products Because of Possible Health Risk
Garden-Fresh Foods is initiating an expansion to our voluntary recall on various ready-to-eat salads, slaw, and dip products sold under various brands and code dates (see attachment). The products may be contaminated with Listeria monocytogenes, an organism that can cause serious and sometimes-fatal infections in young children, frail or elderly people, and others with weakened immune systems.
FDA issues final guidance on mobile medical apps
Today, the U.S. Food and Drug Administration issued final guidance for developers of mobile medical applications, or apps, which are software programs that run on mobile communication devices and perform the same functions as traditional medical devices. The guidance outlines the FDA’s tailored approach to mobile apps.
FDA approval expands access to artificial heart valve for inoperable patients
The U.S. Food and Drug Administration today approved revised labeling for the Sapien Transcatheter Heart Valve (THV), making the device available to an expanded group of patients who have inoperable aortic valve stenosis, a disease of the heart valves that causes narrowing of the aortic valve, restricting blood flow from the heart.
U.S. Marshals seize food products at two Virginia food companies
U.S. Marshals seized food products at Gourmet Provisions, LLC and Royal Cup, Inc., after U.S. Food and Drug Administration investigators found widespread and active rodent and insect infestation on the premises.
FDA finalizes new system to identify medical devices
Today, the U.S. Food and Drug Administration announced a final rule for the unique device identification system (UDI) that, once implemented, will provide a consistent way to identify medical devices.
Semifreddi’s Announces Voluntary Recall of Almond Biscotti and Chocolate Dipped Almond Biscotti for Undeclared Milk and Soy
Semifreddi’s Inc. of Alameda, CA is recalling all packaged Almond Biscotti and Chocolate Dipped Almond Biscotti because the food allergens milk and soy were not declared on the product labels. People who have an allergy or severe sensitivity to milk or soy run the risk of serious allergic reaction, including anaphylaxis, if they consume the products.
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FDA and NIH create first-of-kind Tobacco Centers of Regulatory Science
The U.S. Food and Drug Administration (FDA) and the National Institutes of Health (NIH) today, as part of an on-going interagency partnership, have awarded a total of up to $53 million to fund tobacco-related research in fiscal year 2013 to create 14 Tobacco Centers of Regulatory Science (TCORS).
Baxter Initiates Voluntary Recall of Two Lots of Dual Luer Lock Caps
Baxter International Inc. announced today it has initiated a voluntary recall of two lots of its Dual Luer Lock Caps (Product Code 2C6250, Lots 10043 and 10044) because of the presence of loose particulate matter found in the packaging. Particulate matter entering the fluid path from the Luer Lock Caps may result in thrombotic and embolic events, including: pulmonary embolism, myocardial infarction and stroke.
Wegmans Food Markets Issues Allergy Alert on Undeclared Soy (Allergen) in Wegmans Apple Cinnamon Mini Muffins, 14 oz.
Wegmans is recalling 4,327 units of Wegmans brand APPLE CINNAMON Mini Muffins, Net Wt. 14 oz., because the product contains undeclared soy. People who have an allergy to soy run the risk of serious or life-threatening allergic reaction if they consume this product.