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.
Category Archives: Food & Drug Recalls
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 CUBICINĀ® (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.
Sunburst Superfoods Recalls Organic Raw Carob Powder Because of Possible Health Risk
Sunburst Superfoods of Tuckahoe, NY, is recalling Sunburst SUPERFOODS Organic Raw Carob Powder sold from March 12, 2014 through July 28th, 2014, because it has 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.
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FDA expands approval of drug to treat Pompe disease to patients of all ages; removes risk mitigation strategy requirements
The U.S. Food and Drug Administration today announced the approval of Lumizyme (alglucosidase alfa) for treatment of patients with infantile-onset Pompe disease, including patients who are less than 8 years of age. In addition, the Risk Evaluation and Mitigation Strategy (REMS) known as the Lumizyme ACE (Alglucosidase Alfa Control and Education) Program is being eliminated.