Detox Transforms Health and Nutrition, Garner, NC announced it is conducting a voluntary recall of the following dietary supplements, to the consumer level, because they contain undeclared drug ingredients making them unapproved drugs. FDA analysis found iNDiGO and BtRim Max to contain undeclared phenolphthalein.
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FDA clears system to reduce stroke risk during stent and angioplasty procedures
The U.S. Food and Drug Administration today cleared for marketing the ENROUTE Transcarotid Neuroprotection System (ENROUTE TNS), for use during a minimally invasive procedure to restore normal blood flow to narrowed carotid arteries. It is the first device designed to access the carotid arteries through an incision in the neck, instead of the groin, and uses a blood flow reversal system to capture pieces of the blockage dislodged during the procedure.
See’s Candies, Inc. Issues Allergy Alert on Undeclared Nuts in 8 Oz Classic Red Heart with Assorted Chocolates
See’s Company of San Francisco is recalling all 8 oz Classic Red Hearts with Assorted Chocolates with bar code 737666091201 and stamped date L.A.N. 048/15 because it contains undeclared tree nuts. People who have an allergy or severe sensitivity to tree nuts (e.g.: almonds, walnuts, pecans, coconut) run the risk of serious or life-threatening allergic reaction if they consume these products.
Bimbo Bakeries USA Issues Allergy Alert and Voluntary Regional Recall of Thomas’, Sara Lee and Jewel Bagels Sold in Select Midwest States
Bimbo Bakeries USA is voluntarily recalling Thomas’, Sara Lee and Jewel Bagels because they may contain undeclared peanuts and almonds. People who have allergies to peanuts and almonds run the risk of serious or life-threatening allergic reaction if they consume the products.
Korean Food Co. Recalls Soybean Sprout Because of Possible Health Risk
Korean Food Co. of Irving Texas is recalling 8 boxes of (20 bag in each box) Go-Hang Soybean sprouts in 1 lb. and 2 lb. bags distributed Jan 30, 2015 – Feb 6, 2015 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.
FDA approves Lucentis to treat diabetic retinopathy in patients with diabetic macular edema
The U.S. Food and Drug Administration today expanded the approved use for Lucentis (ranibizumab injection) 0.3 mg to treat diabetic retinopathy (DR) in patients with diabetic macular edema (DME).
J.J. Fuds, Inc. Expands Recall of Pet Food Because of Possible Health Risk
J.J. Fuds in Valparaiso, IN is expanding their recall to include all lots and products of J.J. Fuds Chicken Tender Chunks, Beef Tender Chunks and Duckling Tender Chunks Pet Food because it has the potential to be contaminated with Listeria monocytogenes and or Salmonella, organisms 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. Expands Allergy Alert Due to the Potential for Undeclared Soy in Select Lots of Joseph’s Bread Products and Trader Joe’s Pita Products
Middle East Bakery, Inc. of Lawrence, Massachusetts is recalling select lots of bread products bearing the Joseph’s and Trader Joe’s brand names because they may contain undeclared soy. People who have an allergy or severe sensitivity to soy run the risk of serious or life-threatening allergic reaction if they consume these products.
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Christ Kitchen Issues Allergy Alert on Undeclared Milk in Blameless Blondies Cookie Bar
Christ Kitchen of Spokane, Washington is recalling 199/15 oz. packages of Blameless Blondies Brownie because it may contain undeclared milk. People who have an allergy or severe sensitivity to milk may run the risk of serious or life-threatening allergic reaction if they consume this product.
Federal judge approves consent decree with Maquet Holding B.V. & Co.
A federal judge from the U.S. District Court for the District of New Hampshire has entered a consent decree of permanent injunction against Maquet Holding B.V. & Co. KG (Maquet), and two of the company’s officers, Heinz Jacqui and Gail Christie, for repeatedly failing to correct violations at three of its companies, which are also named on the consent decree: Atrium Medical Corporation (Atrium) in Hudson, New Hampshire; Maquet Cardiovascular, LLC (Maquet CV) in Wayne, New Jersey; and Maquet Cardiopulmonary AG (Maquet CP) in Rastatt and Hechingen, Germany.