Generic drug manufacturer agrees to remedy deviations from the current good manufacturing practice requirements and to correct data integrity problems at numerous facilities
Category Archives: Food Safety News
Maine company holds cold smoked salmon product after FDA order
A Maine food processing and storage company destroyed its cold smoked salmon product under the supervision of the U.S. Food and Drug Administration after inspectors found Listeria monocytogenes within the firm’s facility and on processing equipment
FDA permits marketing of first test for risk of rare brain infection in some people treated with Tysabri
Today, the U.S. Food and Drug Administration allowed marketing of the first test to help determine the risk for a rare brain infection called progressive multifocal leukoencephalopathy (PML) in people using the drug Tysabri (natalizumab) to treat multiple sclerosis (MS) or Crohn’s disease (CD).
Kradjian Imp Co Is Doing An Extended Recall Of Cedar Tree Brand Tresse Cheese And Cedar Tree Brand Shinglish Cheese Because Of Possible Health Risk
Kradjian Imp Co, Glendale, CA is recalling 231 Cases, 22Lb / Cs of Cedar Tree brand Tresse Cheese, 16 oz and Cedar Tree brand Shinglish cheese, 16 oz because they have 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.
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Leasa Industries Co., Inc. Recalls Leasa Brand 6 oz. Living Alfalfa Sprouts Because Of Possible Health Risk
Leasa Industries Co., Inc. of Miami, FL is recalling 346 cases of LEASA Living Alfalfa Sprouts with use by date 2/1/12, 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 approves Voraxaze to treat patients with toxic methotrexate levels
The U.S. Food and Drug Administration today approved Voraxaze (glucarpidase) to treat patients with toxic levels of methotrexate in their blood due to kidney failure.
Methotrexate is a commonly used cancer chemotherapy drug normally eliminated from the body by the kidneys. However, patients receiving high doses of methotrexate may develop kidney failure.
FDA completes work on three drug user fee programs
The U.S. Food and Drug Administration has completed its recommendations for three user fee programs that will help speed safe and effective drugs and lower-cost generic drug and biosimilar biological products to patients, FDA Commissioner Margaret A. Hamburg, M.D. said today. The recommendations were transmitted to Congress today by Health and Human Services Secretary Kathleen Sebelius.
Rich Products Corporation announces nationwide voluntary recall of 1/4 (Quarter) Sheet Vanilla Flavored Pre-Soaked Sponge Cake Artificially Flavored
Rich Products Corporation recalled its 1/4 (quarter) Sheet Vanilla Flavored Pre-Soaked Sponge Cake Artificially Flavored (Product Code: 00405) on January 5, 2012, because small plastic fragments from the packaging were found on top of the product. The size of the fragments range from 1/4 (one fourth) to 3/4(three fourths) inches.
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Bloch’s Best Inc Issues Allergy Alert On Undeclared Eggs in Laromme Brand Vanilla Rugelach in 14 oz. Round Containers
Bloch’s Best Inc doing business as Laromme of Monsey, NY is recalling Laromme brand Vanilla Rugelach in 14 oz. round containers because it may contain undeclared eggs. People who have an allergy or severe sensitivity eggs run the risk of serious or life-threatening allergic reaction if they consume these products.
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FDA to protect important class of antimicrobial drugs for treating human illness
The U.S. Food and Drug Administration today issued an order that prohibits certain uses of the cephalosporin class of antimicrobial drugs in cattle, swine, chickens and turkeys effective April 5, 2012.