On August 8, 2014, the U.S. Department of Justice, at the request of the U.S. Food and Drug Administration, filed a complaint for permanent injunction in the U.S. District Court for the Eastern District of Michigan against S. Serra Cheese Company, of Clinton Township, Michigan, and its owners, Stefano Serra and Fina Serra.
FDA approves first non-invasive DNA screening test for colorectal cancer
The U.S. Food and Drug Administration today approved Cologuard, the first stool-based colorectal screening test that detects the presence of red blood cells and DNA mutations that may indicate the presence of certain kinds of abnormal growths that may be cancers such as colon cancer or precursors to cancer.
Cubist Pharmaceuticals Issues Voluntary Nationwide Recall of Nine Lots of CUBICIN (daptomycin for injection) 500 mg in 10 mL single use vials Following Complaints of Foreign Particulate Matter in Reconstituted Vials
Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) today announced it is voluntarily recalling nine lots of CUBICIN (daptomycin for injection) to the user level following complaints of foreign particulate matter in reconstituted vials. The administration of particulate matter, if present in an intravenous drug, poses a potential safety risk to patients such as a thromboembolism or a life-threatening pulmonary embolism.
Regeneca Worldwide, A Division Of Vivaceuticals, Inc Voluntarily Recalls RegenESlim Appetite Control Capsules Due To The Presence Of DMAA That May Pose Possible Health Risk
Regeneca Worldwide a division of VivaCeuticals, Inc. Las Vegas, NV is conducting a voluntary nationwide recall of its RegenESlim appetite control dietary supplement from lot # EX0616R15814 and lot #11414RE5516 because FDA analysis confirmed the presence of DMAA. DMAA is also known as 1,3-dimethylamylamine, methylhexanamine, or geranium extract. DMAA is commonly used as a stimulant, pre-workout, and weight loss ingredient in dietary supplement products. The Food and Drug Administration (FDA) has warned that DMAA is potentially dangerous to health as it can narrow blood vessels and arteries, which can cause a rise in blood pressure or other cardiovascular problems such as shortness of breath, arrhythmias, tightening in the chest, and heart attack.
Cubist Pharmaceuticals Issues Voluntary U.S. Recall Of Certain Lots Of CUBICIN (Daptomycin For Injection) 500 mg In 10 mL Single Use Vials Due To Presence Of Particulate Matter
Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) today announced it is voluntarily recalling certain lots of CUBICIN® (daptomycin for injection) to the user level due to the potential presence of glass particulate matter in vials produced by a contract manufacturer. Please click here for the list of affected CUBICIN lot information.
FDA approves Orbactiv to treat skin infections
The U.S. Food and Drug Administration today approved Orbactiv (oritavancin), a new antibacterial drug to treat adults with skin infections.
Seoul Shik Poom Inc. Issues Allergy Alert on Undeclared Eggs in Choripdong Chocolate Almond Richmond Ice Bar
Seoul Shik Poom Inc. of Englewood, NJ is recalling Choripdong Chocolate Almond Richmond Ice Bar (4bags/432ml) because they may contain undeclared eggs. People who have an allergy or severe sensitivity to eggs run the risk of serious or life-threatening allergic reaction if they consume this product.
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Oasis Brands, Inc Recalls Quesito Casero 12oz Because Of Possible Health Risk
Oasis Brands, Inc of Miami, FL is recalling Quesito Casero 12oz with expiration date 09/27/14, 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.
Ortho Molecular Products Issues Allergy Alert On Undeclared Milk In Lifecore Chocolate And Lifecore Complete Chocolate
Ortho Molecular Products of Stevens Point, Wisconsin is recalling all lots of LifeCore Chocolate and LifeCore Complete Chocolate because the flavoring may contain undeclared milk. According to food safety standards, people who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume this product.
New England Greens, LLC dba Vibrant Health Recalls Green Vibrance and Rainbow Vibrance Because of Possible Health Risk
New England Greens of Canaan, Connecticut is recalling 10 lots of Green Vibrance and one lot of Rainbow Vibrance after a former raw material supplier, Raw Deal of Allamuchy, NJ, recalled the Organic Parsley Leaf Powder used to manufacture Green Vibrance and Rainbow Vibrance because of the potential for contamination with Salmonella. Although the possibility is slight that any amount of Salmonella is present in any of the recalled lots of the above-mentioned products, New England Greens is issuing the recall with an abundance of caution for the safety of its consumers.