The U.S. Food and Drug Administration today approved Octaplas, a pooled plasma (human) blood product for the replacement of clotting proteins (coagulation factors) in certain medical conditions where patients have insufficient levels. Clotting protein deficiencies can cause excessive bleeding or excessive clotting.
FDA approves new seasonal influenza vaccine made using novel technology
The U.S. Food and Drug Administration today announced that it has approved Flublok, the first trivalent influenza vaccine made using an insect virus (baculovirus) expression system and recombinant DNA technology. Flublok is approved for the prevention of seasonal influenza in people 18 through 49 years of age.
Belmont Confections Issues Allergy Alert on Undeclared Peanuts in “Dymatize Nutrition, Elite Gourmet Bars” (Cookies & Cream and Fudge Brownie)
Belmont Confections Inc. is recalling Dymatize Nutrition Elite Gourmet Cookies & Cream bars and Dymatize Nutrition Elite Gourmet Fudge Brownie bars in both the 1.5oz and 3oz packages because they may contain undeclared peanuts. Belmont became aware of the problem via a complaint to the distributor Dymatize Inc.
Boba Direct Issues Allergy Alert on Undeclared Milk in BD Flavored Powders
Boba Direct (BD) announced the voluntary recall of the following BD Flavored Powders: Almond, Avocado, Banana, Blueberry, Café Latte, Cherry, Chocolate, Coconut, Honeydew, Lavender, Lychee, Mango, Matcha Green Tea, Milk Tea, Passionfruit, Peppermint, Pineapple, Red Bean, Strawberry, Taro, Vanilla and Watermelon in the 2.2 lb. plastic bags because of the incorrect label failing to declare milk as the source of sodium caseinate and lactose. Individuals with allergies to milk run the risk of serious or life-threatening allergic reaction if they consume these products.
Homestead Creamery Artisan Cheese Removed from Store Shelves
Artisan Cheeses
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FDA permits marketing of first test that can simultaneously identify 11 causes of infectious gastroenteritis
The U.S. Food and Drug Administration today allowed marketing for the first test that can simultaneously detect 11 common viral, bacterial and parasitic causes of infectious gastroenteritis from a single patient sample.
Milo’s Kitchen® Voluntarily Recalls Chicken Jerky and Chicken Grillers Home-style Dog Treats
Milo’s Kitchen® today announced that it is voluntarily recalling its Chicken Jerky and Chicken Grillers home-style dog treats from retailer shelves nationally. No other Milo’s Kitchen® products are affected.
Island Delights Volutarily Recalls Island Delights Coconut Haystack Candy Due to Undeclared Milk
Island Delights, Inc. today recalled 492 Bags of its Coconut Haystack Candy due to mislabeling and undeclared allergens. This was discovered during an audit from the Ohio Department of Agriculture on January 7, 2013.
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FDA requiring lower recommended dose for certain sleep drugs containing zolpidem
The U.S. Food and Drug Administration today announced it is requiring the manufacturers of Ambien, Ambien CR, Edluar and Zolpimist, widely used sleep drugs that contain the active ingredient zolpidem, to lower current recommended doses. Ambien and Ambien CR are also available as generics. New data show that zolpidem blood levels in some patients may be high enough the morning after use to impair activities that require alertness, including driving.
Giant & Martin’s Alerts Customers To Voluntary Recall Of Ocean Beauty Seafood Smoked Salmon
GIANT Food Stores, LLC and MARTIN’S Food Markets, following a recall by Ocean Beauty Seafoods LLC, announced it removed from sale several varieties of smoked salmon due to possible contamination by listeria monocytogenes.
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