iTrace for Blood Centers, (Version 1.0.924.0), the first application to use Radio Frequency Identification (RFID) technology in blood establishments to assist in enhancing blood safety by preventing the release of unsuitable blood components, was cleared today by the U.S. Food and Drug Administration.
Main Street Family Pharmacy, LLC Issues Voluntary Nationwide Recall of All Sterile Compounded Products
May 28, 2013 – Newbern, Tennessee–Main Street Family Pharmacy, LLC today announced a voluntary nationwide recall of all lots of all sterile products compounded by the pharmacy. The compounded products that are subject to the recall are those products with a use by date on or before November 20, 2013.
Salmolux Recalls Cold Smoked Salmon Products Because Of Possible Health Risk
Salmolux of Federal Way, WA is recalling its cold smoked salmon products because it has 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 alerts health care providers of adverse reactions associated with steroid injections from Main Street Family Pharmacy in Tennessee
The U.S. Food and Drug Administration is working closely with the Centers for Disease Control and Prevention and Tennessee Board of Pharmacy to investigate reports of seven adverse events associated with steroid injections compounded by Main Street Family Pharmacy, LLC (Main Street) of Newbern, Tenn.
Eco-Cuisine Recalls Product Because of Possible Health Risk (Extended Recall)
Eco-Cuisine of Boulder, Colorado is recalling all lots of T3314 Basic Brownie Mix, T3333 Betty Brownie Mix with Vanilla, T3388 Ground Beef Style Quick Mix, T3394 Sausage Style Quick Mix, T3416 Chocolate Cookie Mix, T3417 Lemon Muffin Mix, and T3418 English Scone Mix, CM25COOK Basic Cookie Mix 25 lb. bag, CM25MUFF Basic Muffin Mix 25 lb. bag, CM25SCON Basic Scone Mix 25 lb. Bag, 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 allows marketing of first A1c test labeled for diagnosing diabetes
Today the U.S. Food and Drug Administration announced that it is allowing marketing of the COBAS INTEGRA 800 Tina-quant HbA1cDx assay (Tina-quant HbA1cDx assay) for the diagnosis of diabetes by health care professionals. This is the first HbA1c test that FDA has allowed to be marketed for this use.
LL Bakery, Inc. Announces the Recall of White Farm Enriched White Bread, Butter Farm Enriched White Bread, and Italian Cream Danish for Undeclared Milk Allergens
LL Bakery Inc. of Torrance, CA is recalling all White Farm Enriched White Bread, Butter Farm Enriched White Bread, and Italian Cream Danish because product labels fail to declare the allergen “milk”, in the whey powder listed in their ingredient statements. People who have an allergy or severe sensitivity to milk run the risk of a life threatening allergic reaction, anaphylaxis, that requires immediate medical attention should they consume these products.
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Eco-Cuisine Recalls Product Because of Possible Health Risk
Eco-Cuisine of Boulder, Colorado is recalling all lots of T3314 Basic Brownie Mix, T3333 Betty Brownie Mix with Vanilla, T3388 Ground Beef Style Quick Mix, T3394 Sausage Style Quick Mix, T3416 Chocolate Cookie Mix, T3417 Lemon Muffin Mix, and T3418 English Scone Mix, CM25COOK Basic Cookie Mix 25 lb. bag, CM25MUFF Basic Muffin Mix 25 lb. bag, CM25SCON Basic Scone Mix 25 lb. Bag, 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.
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Sandoz US Announces Voluntary Nationwide Recall of two lots of Methotrexate Sodium, USP, Injectable Vials, 25mg/mL, 40mL vials
Sandoz is conducting a voluntary nationwide recall to the hospital/user level of two lots of its Methotrexate Sodium, USP, 25 mg/mL, 40 mL vial injectable product in the US, due to the discovery of particulate matter in vials during routine quality examination of retention samples at the manufacturer. The product is preservative free.
Precautionary Recall Issued For Pre-Packaged Texas Gulf Shrimp
Galveston Shrimp Company has issued a precautionary voluntary recall of its pre-packaged Texas Gulf Shrimp due to foreign material found in a bag. The pre-packaged bags are shipped to HEB Stores. Customers who recently purchased pre-packaged Gulf Shrimp are encouraged to check their refrigerators and/or freezers.