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.
Category Archives: Food & Drug Recalls
FDA approves Zykadia for late-stage lung cancer
The U.S. Food and Drug Administration today granted accelerated approval to Zykadia (ceritinib) for patients with a certain type of late-stage (metastatic) non-small cell lung cancer (NSCLC).
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.
Stonyfield Announces Voluntary Recall of 188 6-packs of Yobaby Peach/Pear Yogurt Cups from 40 Target Stores in the Southeast and 82 Mid-Atlantic Walmart Stores
Organic yogurt maker Stonyfield is voluntarily recalling 188 6-packs of 4 oz YoBaby Peach/Pear cups with the code date June 05 2014 (UPC 052159701161).
The 4 oz 6-packs were shipped to Target stores in Alabama, Virginia, Tennessee, Florida, Georgia, North Carolina and South Carolina and Walmart stores in Pennsylvania, Maryland, New Jersey and Delaware.
FDA approves first human papillomavirus test for primary cervical cancer screening
The U.S. Food and Drug Administration today approved the first FDA-approved HPV DNA test for women 25 and older that can be used alone to help a health care professional assess the need for a woman to undergo additional diagnostic testing for cervical cancer. The test also can provide information about the patient’s risk for developing cervical cancer in the future.
FDA approves Sylvant for rare Castleman’s disease
The U.S. Food and Drug Administration today approved Sylvant (siltuximab) to treat patients with multicentric Castleman’s disease (MCD), a rare disorder similar to lymphoma (cancer of the lymph nodes).
FDA proposes to extend its tobacco authority to additional tobacco products, including e-cigarettes
As part of its implementation of the Family Smoking Prevention and Tobacco Control Act signed by the President in 2009, the U.S. Food and Drug Administration today proposed a new rule that would extend the agency’s tobacco authority to cover additional tobacco products.
Miravalle Foods, Inc. Recalls Ground Annato Because of Possible Health Risk
Miravalle Foods, Inc. of El Monte, CA, is conducting a voluntarily recall on its 0.75 ounce packages of Miravalle brand Achiote Molido Ground Annato spice 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. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain.
Nano Well-being Health Inc. Issues Voluntary Nationwide Recall of Super Arthgold Due to Undeclared Ingredients
La Mirada, CA, Nano Well-being Health Inc. is voluntarily recalling lot L1P1-6100/Expiration date June 25, 2016 and lot L1P2-6000/Expiration date September 16, 2016 of Super Arthgold, 500 mg capsules to the consumer level. FDA laboratory analysis has found the product to contain chlorzoxazone, diclofenac and indomethacin, making it an unapproved new drug.
FDA proposes new expedited access program for medical devices that address unmet medical needs
Today, the U.S. Food and Drug Administration proposed a new program to provide earlier access to high-risk medical devices that are intended to treat or diagnose patients with serious conditions whose medical needs are unmet by current technology.