The U.S. Food and Drug Administration today approved the Immucor PreciseType Human Erythrocyte Antigen (HEA) Molecular BeadChip Test – the first FDA-approved molecular assay used in transfusion medicine to assist in determining blood compatibility. The assay can be used to determine donor and patient non-ABO/non-RhD (non-ABO) red blood cell types in the United States.
FDA approves Entyvio to treat ulcerative colitis and Crohn’s disease
The U.S. Food and Drug Administration today approved Entyvio (vedolizumab) injection to treat adult patients with moderate to severe ulcerative colitis and adult patients with moderate to severe Crohn’s disease.
Lansal, Inc. Voluntarily Recalls Hummus & Dip Products Due to Possible Health Risk
Prepared Foods manufacturer, Lansal, Inc.( d.b.a Hot Mama’s Foods), announced today that as a precaution it is voluntarily recalling approximately 14,860 pounds of hummus and dip products due to concerns about possible 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.
Middle East Bakery, Inc. Issues Allergy Alert on Undeclared Milk in Market Basket Dairy-free, Gluten-free Pancakes
Middle East Bakery of Lawrence, MA is recalling all lots of Market Basket Dairy-Free, Gluten-Free Pancakes, because they may contain undeclared milk. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products.
Kraft Foods Group Voluntarily Recalls Select Cottage Cheese Products Due to Out-of-Standard Storage Temperatures
Kraft Foods Group is voluntarily recalling select Knudsen Cottage Cheese, Breakstone’s Cottage Cheese, Simply Kraft Cottage Cheese, and Daily Chef Cottage Cheese products. Some ingredients used in these products were not stored in accordance with Kraft’s temperature standards.
WhiteWave Foods Issues Allergy Alert on Undeclared Almondmilk in Half Gallon Silk Light Original Soymilk Containers
WhiteWave Foods is voluntarily recalling half gallon containers of Silk Light Original Soymilk because they may contain undeclared almondmilk. People who have an allergy or sensitivity to almond run the risk of serious or life threatening allergic reaction if they consume this product.
Allergy Alert on Undeclared Milk in Pancakes
American Waffle Company of Clayton, Delaware is voluntarily recalling 480 cases of Gluten Free Blueberry Pancakes with Best By or Sell By 07/31/15 because the product contains undeclared milk. People who have an allergy or severe sensitivity to milk may be at risk of serious or life threatening allergic reaction if they consume this product.
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Hospira Announces Voluntary Nationwide Recall Of One Lot Of Labetalol Hydrochloride Injection, USP, 100 MG/20 ML (5MG/ML), 20 ML, Multidose Vial, Due To Visable Particulates
Hospira, Inc. (NYSE: HSP), announced today it will initiate a voluntary nationwide recall to the user level for one lot of Labetalol Hydrochloride Injection, USP, 100 mg/20 mL (5 mg/mL) 20 mL Multidose Vial, NDC 0409-2267-20, Lot 36-225-DD, Expiration 12/01/2015.
Ventlab, LLC. Issues a Nationwide Recall of Ventlab Resuscitator Bags Due to Possible Health Risk
Ventlab LLC. of Grand Rapids, Michigan has initiated a voluntary medical device removal of a limited number of Ventlab™ Resuscitator Bags after becoming aware of complaints regarding a sticking duckbill valve that resulted in the resuscitation bags delivering no air through the patient valve, to the patient. The valves may stick due to incomplete curing during the manufacturing process.
U.S. Marshals seize unapproved drugs from Ohio distributor
U.S. Marshals, at the request of the U.S. Food and Drug Administration and the U.S. Attorney for the Southern District of Ohio, have seized more than $11,185,000 worth of unapproved drugs marketed by Ascend Laboratories of Montvale, N.J. and distributed by Masters Pharmaceuticals, Inc. of Cincinnati, Ohio.