The U.S. Food and Drug Administration today announced it required the manufacturer of the sleep drug Lunesta (eszopiclone) to change the drug label and lower the current recommended starting dose. Data show that eszopiclone levels in some patients may be high enough the morning after use to impair activities that require alertness, including driving, even if they feel fully awake.
Category Archives: Food Safety News
FDA allows marketing of first prosthetic arm that translates signals from person’s muscles to perform complex tasks
The U.S. Food and Drug Administration (FDA) today allowed marketing of the DEKA Arm System, the first prosthetic arm that can perform multiple, simultaneous powered movements controlled by electrical signals from electromyogram (EMG) electrodes.
Strong America Limited ISSUES ALLERGY ALERT ON UNDECLARED EGG IN “Golden Smell Hotpot Meat Ball Medley”
Strong America Limited of Long Island City, New York is recalling its 1 pound package of “Golden Smell Hotpot Meat Ball Medley” food treats because they may contain undeclared eggs.
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FDA allows marketing of first prosthetic arm that translates signals from person’s muscles to perform complex tasks
The U.S. Food and Drug Administration (FDA) today allowed marketing of the DEKA Arm System, the first prosthetic arm that can perform multiple, simultaneous powered movements controlled by electrical signals from electromyogram (EMG) electrodes.
FDA approves Zontivity to reduce the risk of heart attacks and stroke in high-risk patients
The U.S. Food and Drug Administration today approved Zontivity (vorapaxar) tablets to reduce the risk of heart attack, stroke, cardiovascular death, and need for procedures to restore the blood flow to the heart in patients with a previous heart attack or blockages in the arteries to the legs.
STE Fromagere Du Livradois Voluntarily Recalls Raclette Cheese and Montboissie Cheese for Possible Health Risk
Ste Fromagere du Livradois of Fournols, France is recalling Haut Livradois brand Raclette and Montboissie cheeses lot#350 because they have the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.
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Sixdog Investments Voluntarily Recalls Eggs Because of Possible Health Risk
Sixdog Investments, LLC is voluntarily recalling some cases of their certified organic eggs, because of the potential they are contaminated with Salmonella. This voluntary field action was initiated because of routine testing results, and not because of illness to date from consumption.
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NOH Foods Of Hawaii Issues Allergy Alert On Undeclared Milk In Hawaiian Coconut Pudding Haupia (LUAU Dessert)
NOH FOODS OF HAWAII, of Honolulu, HI and Gardena, CA is voluntarily recalling its 2 ounce,
4 ounce, and 3 lb. (48 oz) packages of “Hawaiian Coconut Pudding” because they may contain undeclared dairy product.
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United States enters consent decree with New York cheese producer due to Listeria contamination
On April 28, 2014, United States District Court Judge Richard J. Arcara of the Western District of New York entered a consent decree of permanent injunction between the United States and Finger Lakes Farmstead Cheese Company, LLC, of Trumansburg, N.Y. and its co-owner Nancy Taber Richards. The consent decree was pursued by the U.S. Attorney’s Office for the Western District of New York on behalf of the U.S. Food and Drug Administration.
FDA issues proposals to address risks associated with surgical mesh for transvaginal repair of pelvic organ prolapse
The U.S. Food and Drug Administration today issued two proposed orders to address the health risks associated with surgical mesh used for transvaginal repair of pelvic organ prolapse (POP). If finalized, the orders would reclassify surgical mesh for transvaginal POP from a moderate-risk device (class II) to a high-risk device (class III) and require manufacturers to submit a premarket approval (PMA) application for the agency to evaluate safety and effectiveness.