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.
FDA expands alert to health care providers about lack of sterility assurance of all sterile drug products from NuVision Pharmacy
The U.S. Food and Drug Administration is alerting health care providers of concerns about a lack of sterility assurance of all sterile drug products made and distributed by NuVision Pharmacy of Dallas, Texas. The FDA recommends that these products should not be administered to patients.
FDA seeks preliminary injunction against New York fish manufacturer
The U.S. Department of Justice, on behalf of the U.S. Food and Drug Administration (FDA), is seeking a preliminary injunction in the U.S. District Court for the Eastern District of New York against New York City Fish, Inc., and several key employees for manufacturing and distributing ready-to-eat fish products under insanitary conditions causing them to become adulterated.
Pentec Health Announces Limited Voluntary Recall of Certain Compounded Prescription Therapies for Renal Patients
Pentec Health, Inc. has decided to initiate a limited, voluntary recall of in-date nutritional prescriptions for renal patients due to lack of sterility assurance associated with one of its laminar flow hoods used in compounding.
The recall covers renal therapies that were compounded in this hood on or before May 2, 2013.
Tropical Valley Foods Issues Allergy Alert on Undeclared Milk and Walnuts in Next by Nature Dark Chocolate Bananas
Tropical Valley Foods Inc. of Plattsburgh, NY, is recalling next by Nature DARK CHOCOLATE BANANAS, 3 oz. bags, due to undeclared milk and walnuts. People who have an allergy to milk and/or walnuts run the risk of serious or life-threatening allergic reaction if they consume this product.
Rural King Recalls Deer Corn Because of Possible Health Risk
Rural King Distributing of Mattoon, IL is recalling 205 tons of Deer Corn, because it has the potential to be contaminated with aflatoxin. Aflatoxin is a naturally occurring mold by-product.