Whalen’s Horseradish Products, Inc. of Galway, NY is recalling WHALEN’S SEAFOOD & BURGER SAUCE, because it contains undeclared anchovy, an element of the Worcestershire Sauce used in the finished product. People who have an allergy to fish run the risk of a serious or life-threatening allergic reaction if they consume this product.
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Del Monte Fresh Produce N.A., Inc. Voluntarily Recalls Fresh Cut Fruit Containing Gala Red Apple in a Few States in North East US Because of Possible Health Risk
Del Monte Fresh Produce N.A., Inc. (“Del Monte Fresh”) announced today the voluntary recall of fresh cut fruit containing Gala red apples grown in Pennsylvania. The affected product was distributed to a limited number of customers in a few States in North East US and is being recalled because these apples have the potential to 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.
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FDA approves Gardasil 9 for prevention of certain cancers caused by five additional types of HPV
The U.S. Food and Drug Administration today approved Gardasil 9 (Human Papillomavirus 9-valent Vaccine, Recombinant) for the prevention of certain diseases caused by nine types of Human Papillomavirus (HPV). Covering nine HPV types, five more HPV types than Gardasil (previously approved by the FDA), Gardasil 9 has the potential to prevent approximately 90 percent of cervical, vulvar, vaginal and anal cancers.
Global Garlic Inc. Recalls De Mi Pais Products Cuajada Fresca (Fresh Curd) and Cuajada Olanchana (Fresh Curd) because of Possible Health Risk
Global Garlic, Inc. of Miami, FL is recalling De Mi Pais products: Cuajada Fresca (Fresh Curd) 12oz. and Cuajada Olanchana (Fresh Curd) 12oz., because it has 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.
Alere Initiates Voluntary URGENT CORRECTION for Use of Alere INRatio and INRatio2 PT/INR Monitor System
Alere Inc. (NYSE:ALR) has initiated a voluntary correction to inform U.S. users of the Alere INRatio and INRatio2 PT/INR Monitor system of certain medical conditions that should not be tested with the system (INRatio Monitor or INRatio2 Monitor and INRatio Test Strips). In certain cases an INRatio and INRatio2 PT/INR Monitor system may provide an INR result that is clinically significantly lower than a result obtained using a reference INR system (laboratory method).
OtisMed Corporation, former CEO plead guilty for distributing FDA-rejected cutting guides for knee replacement surgeries
OtisMed Corporation (OtisMed) and its former chief executive officer, Charlie Chi, admitted today to intentionally distributing knee replacement surgery cutting guides after their application for marketing clearance had been rejected by the U.S. Food and Drug Administration.
Safeway Recalls Safeway Select French Salted Caramel (Fleur De Sel) Premium Ice Cream Sold November 4 through December 5 Due to an Undeclared Peanut Allergen
Safeway is voluntarily recalling Safeway Select French Salted Caramel (Fleur De Sel) Premium Ice Cream sold in all Safeway-owned stores from November 4, 2014 through December 5, 2014 due to the inclusion of an undeclared peanut allergen.
House of Flavors Issues Voluntary Recall Due to Possible Undeclared Dairy Allergen in Ciao Bella Dark Cocoa Sorbetto
House of Flavors, Inc., based in Ludington, Michigan, is recalling Ciao Bella Dark Cocoa Sorbetto manufactured by House of Flavors because it’s ingredients may include an undeclared dairy allergen. Consumers who may have an allergy or severe sensitivity to dairy run the risk of serious or life-threatening allergic reaction if they consume this product.
Abdallah Candies Announces the Voluntary Recall of Holiday Caramel Bites
Abdallah Candies of Burnsville, MN is taking precautionary measures and voluntarily recalling red and silver foil wrapped Holiday Caramel Bites. One customer has reported finding a peanut butter bite, wrapped in red foil, in a bag of holiday caramel bites.
FDA resolves criminal and civil actions against Main Street Family Pharmacy
Main Street Family Pharmacy, LLC, a compounding pharmacy in Newbern, Tennessee, and the company’s co-owner, David A. Newbaker, each pleaded guilty today in the United States District Court for the Western District of Tennessee to one misdemeanor criminal violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act).