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).
Category Archives: Food & Drug Recalls
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).
Lakeland Animal Nutrition Issues Voluntary Horse Feed Recall
Lakeland Animal Nutrition has been informed that certain horse feeds manufactured by the company in Lakeland, Florida and distributed within the state of Florida may contain monensin and lasalocid. Serious injury or death can occur in horses consuming feeds containing monensin and/or lasalocid.
FDA approves Jakafi to treat patients with a chronic type of bone marrow disease
The U.S. Food and Drug Administration today approved a new use for Jakafi (ruxolitinib) to treat patients with polycythemia vera, a chronic type of bone marrow disease. Jakafi is the first drug approved by the FDA for this condition.
California seafood company to halt production until FDA documents correction of unsanitary practices
On December 1, a federal judge from the U.S. District Court for the Central District of California entered a consent decree of permanent injunction against Neptune Manufacturing, Inc., of Los Angeles, and its owners, Alexander Goldring, Peter Oyrekh and Semyon Krutovsky.
Overhill Farms Voluntarily Recalls Open Nature Chile Cheese Enchiladas Sold At Safeway Stores Nationwide Due To Possible Salmonella Contamination
Overhill Farms, Inc. of Vernon, California is voluntarily recalling the frozen food product Open Nature Chile Cheese Enchiladas due to potential Salmonella contamination.