December 26, 2017
AuroMedics Pharma LLC is voluntarily recalling one lot of Linezolid Injection 600mg/300mL flexible bags, NDC 55150 -242 -51 batch CLZ160007 expiration August 2018 to the hospital level. This batch was distributed May 15 through August 14, 2017. The product was found to contain white particulate matter that has been identified as mold. This problem was […]
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December 26, 2017
FDA discusses the steps taken to improve the recall process, the HHS OIG report on recalls, and new policies being considered.
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December 23, 2017
Nodine’s Smokehouse, Inc. of Torrington, Connecticut is recalling Smoked Salmon 1.5 lbs, 8 oz packages. Lot numbers 40173 and 33173 because they have the potential to be contaminated with Listeria monocytogenes. Consumption of food contaminated with Listeria monocytogenes can cause listeriosis, with high fever, severe headache, neck stiffness, and nausea as its primary symptoms. In […]
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December 22, 2017
Harris Teeter is notifying 153 shoppers who purchased HT Traders Mama Biscotti Mini Biscotti – Triple Chocolate since Dec. 8, 2017. The company’s supplier, Mom’s Best Gourmet Foods, Inc., is issuing a voluntary recall due to potential undeclared almonds and hazelnuts. The company has notified the shoppers for which it has customer data via telephone […]
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December 22, 2017
Fresh Pak Inc. of Detroit, MI is announcing a voluntary Lot specific recall of red/green apple slices. Jack Brown Produce, Inc. (supplier) requested Fresh Pak Inc. to perform a recall for the reason that they could have potentially been contaminated with Listeria monocytogenes, an organism that can cause serious and sometimes fatal infections in young […]
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December 22, 2017
FDA updates the label of Tasigna to reflect that certain patients with a type of leukemia may be eligible to stop treatment after sustained response
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December 22, 2017
FDA clears stereotactic radiotherapy system for use in treating breast cancer
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December 21, 2017
Springfield Smoked Fish of Springfield, MA is expanding their voluntary recall to include additional smoked fish and cream cheese products because they have the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may […]
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December 21, 2017
The FDA today approved the new drug Giapreza (angiotensin II) injection for intravenous infusion to increase blood pressure in adults with septic or other distributive shock.
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December 21, 2017
As a result of the Fresh-Pak Inc. recall, Meijer is announcing a voluntary recall of select Meijer brand packaged products due to sliced apples within the products being potentially contaminated with Listeria monocytogenes. To date, there have been no known illnesses reported in connection with this recall.
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December 19, 2017
Springfield Smoked Fish of Springfield, MA is expanding their voluntary recall of smoked fish products because they have the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such […]
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December 19, 2017
Gel Spice Company, Inc. is voluntarily recalling certain Spice Time and Spice Supreme Beef Flavored Bouillon Cube products (identified below) because they contain undeclared soy and wheat. People who have an allergy or severe sensitivity to soy and/or wheat run the risk of serious or life-threatening allergic reaction(s) if they consume these products.
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December 19, 2017
East Windsor, New Jersey, AuroMedics Pharma LLC is voluntarily recalling one lot of Pantoprazole Sodium for Injection 40 mg per vial, to the hospital level. The product was found to contain glass particles in the vial. This problem was discovered as a result of a product complaint in which the contents of one vial from […]
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December 19, 2017
Jack Brown Produce, Inc. of Sparta, MI is recalling Gala, Fuji, Honeycrisp and Golden Delicious apples processed and shipped by one of its suppliers, Nyblad Orchards, Inc., on December 11 through December 16, 2017, because they have the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections […]
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December 19, 2017
FDA approves novel gene therapy to treat patients with a rare form of inherited vision loss
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December 18, 2017
Today, the U.S. Food and Drug Administration proposed a new, risk-based enforcement approach to drug products labeled as homeopathic. To protect consumers who choose to use homeopathic products, this proposed new approach would update the FDA’s existing policy to better address situations where homeopathic treatments are being marketed for serious diseases and/or conditions but where […]
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December 15, 2017
FDA issues two draft guidances that will provide medical product developers with greater clarity on the FDA’s recommendations for researching and developing the next generation of individualized therapies.
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December 13, 2017
Orange, CA, Marmex Corp is voluntarily recalling All lots of Blue Pearl All Natural Male Enhancement Supplement, 500mg to the consumer level. FDA analysis has found the products to contain sildenafil.
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December 13, 2017
Springfield Smoked Fish of Springfield, Ma.is recalling its 1lb. packages Prescliced Nova Salmon because they have the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious 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 […]
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