A new study is helping to provide a better understanding of vaccines for whooping cough, the common name for the disease pertussis. Based on an animal model, the study conducted by the U.S. Food and Drug Administration (FDA) and published November 25, 2013, in The Proceedings of the National Academy of Sciences, shows that acellular pertussis vaccines licensed by the FDA are effective in preventing the disease among those vaccinated, but suggests that they may not prevent infection from the bacteria that causes whooping cough in those vaccinated or its spread to other people, including those who may not be vaccinated.
Category Archives: Food & Drug Recalls
Abbott Issues Voluntary Recall of Certain FreeStyle® and FreeStyle Lite® Blood Glucose Test Strips in the United States
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.
Flat Creek Farm and Dairy Recalls Heavenly Blue Because of Possible Health Risk
Flat Creek Farm and Dairy of Swainsboro, GA has recalled 200 pounds of Heavenly Blue cheese, because of potential contamination. As of November 27, 2013 at 11:00am, according to Flat Creek records, all of the purchasers have been notified and more than 90% of the product has been collected or destroyed.
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.