Abbott today announced it is initiating a voluntary recall of 20 lots of FreeStyle® and FreeStyle Lite® Blood Glucose Test Strips in the United States. These lots of test strips may produce erroneously low blood glucose results when used with both “FreeStyle® Blood Glucose Meter” and “FreeStyle® Flash Blood Glucose Meter” [neither of which have been in production since 2010], as well as the OmniPod® Insulin Management System.
Baxter Initiates Nationwide Voluntary Recall of One Lot of Nitroglycerin in 5% Dextrose Injection
Baxter International Inc. announced today it has initiated a voluntary recall of one lot of Nitroglycerin in 5% Dextrose Injection due to particulate matter found in one vial. If infused, particulate matter could lead to potential venous and/or arterial thromboembolism (blockage of blood vessels.)
Zip International Group LLC Recalls Herring Fillet in Oil Due to Potential Health Risk
ZIP INTERNATIONAL GROUP LLC, 160 Raritan Center Parkway #6, Edison, NJ 08837, is recalling herring fillet in oil (FOSFOREL, ATLANTIKA) 400 gram in plastic packaging due to Listeria contamination.
FDA requires removal of certain restrictions on the diabetes drug Avandia
The U.S. Food and Drug Administration today announced it is requiring the removal of certain restrictions on prescribing and use of the diabetes drug Avandia (rosiglitazone) to reflect new information regarding the cardiovascular risk of the medicine. Today’s actions are consistent with the recommendations of expert advisory committees.
CLR Medicals International Inc. Issues Nationwide Recall of Viscoelastic Products
CLR Medicals International Inc., initiated a nationwide recall of Viscocel and Viscocel Plus, in response to FDA inspectional findings of deficiencies in the Quality System regulations for Medical Device Manufacturers, 21 Code of Federal Regulation (CFR) Part 820 and lack of Premarket Approval (PMA) for devices sold or distributed in domestic commerce. The Viscoelastic products, intended for human and animal use, have been determined to be a public health concern due to distribution in the US without FDA approval, which evaluates the safety and efficacy of the product, and violations of the QSR regulations related to sterility, and biocompatibility that may result in the release of contaminated products.
Jayone Food Issues Voluntary Alert on Undeclared Peanuts in Dried Seaweed Salad
Jayone Foods, inc. of Paramount, CA is voluntarily recalling All date codes of Trader Joe’s Dried Seaweed Salad with Spicy Dressing (SKU 97677), because it may contain traces of peanuts. People who have an allergy or severe sensitivity to peanuts run the risk of serious or life-threatening allergic reaction if they consume this product.
FDA approves new treatment for hepatitis C virus
The U.S. Food and Drug Administration today approved Olysio (simeprevir), a new therapy to treat chronic hepatitis C virus infection.
FDA approves first adjuvanted vaccine for prevention of H5N1 avian influenza
The U.S. Food and Drug Administration today approved the first adjuvanted vaccine for the prevention of H5N1 influenza, commonly known as avian or bird flu. The vaccine, Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, is for use in people 18 years of age and older who are at increased risk of exposure to the H5N1 influenza virus.
FDA approves Nexavar to treat type of thyroid cancer
The U.S. Food and Drug Administration today expanded the approved uses of Nexavar (sorafenib) to treat late-stage (metastatic) differentiated thyroid cancer.
Marina’s German Bakery Issues Allergy Alert on Undeclared Almonds, Walnuts, and Hazelnuts in Pastry Products
Marina’s German Bakery of El Paso, Texas is recalling two-count packages of pastry products, because they may contain undeclared Almonds, Walnuts, or Hazelnuts. People who have an allergy or severe sensitivity to Almonds, Walnuts, or Hazelnuts run the risk of serious or life threatening allergic reaction if they consume these products.
The two count packages of Assorted Pastries were distributed in El Paso,Texas at Fort Bliss Commissary and in Alamogordo, New Mexico at Holloman AFB Commissary.