The U.S. Food and Drug Administration today approved a new use for Xiaflex (collagenase clostridium histolyticum) as the first FDA-approved medicine to treat men with bothersome curvature of the penis, a condition known as Peyronie’s disease.
FDA reaches $1.25 million settlement with Advanced Sterilization Products and company executives
The U.S. Food and Drug Administration has reached a $1.25 million settlement of a civil money penalty action against Advanced Sterilization Products (ASP), a division of Ethicon Inc., a Johnson & Johnson company, and two of ASP’s executives alleging that ASP manufactured and distributed adulterated and misbranded sterilization monitoring products.
Cargill Conducts Voluntary Recall of Select Nutrena® NatureWise® Meatbird and Chick Starter Feed
Cargill’s animal nutrition business today announced a voluntary recall of two of its Nutrena NatureWise poultry feeds due to incorrect levels of calcium. The affected products were manufactured at Cargill’s facilities in Flora, Ill., Oklahoma City, Okla., Abilene, Texas, and Mineola, Texas, between May 1, 2013 and Nov. 21, 2013.
FDA issues safety communication on HeartStart automated external defibrillators from Philips Healthcare
Certain HeartStart automated external defibrillator (AED) devices made by Philips Medical Systems, a division of Philips Healthcare, may be unable to deliver needed defibrillator shock in a cardiac emergency situation, the U.S. Food and Drug Administration said today in a new safety communication for users of these previously recalled devices.
Huxtable’s Kitchen Issues Voluntary Allergy Alert on Undeclared Allergens in Butternut Squash & Creamed Spinach Gratin
Huxtable’s Kitchen Inc. of Vernon, California is voluntarily recalling one specific lot of Trader Joe’s Butternut Squash & Creamed Spinach Gratin (SKU 96541) sold in the refrigerated section with “Use By 12/13/13” date, because it may not list wheat and egg in the ingredients. People who have an allergy or severe sensitivity to wheat and egg run the risk of serious or life-threatening allergic reaction if they consume this product.
IQ Formulations Issues a Voluntary Recall of HYDRAVAX Dietary Supplement Due to Possible Undeclared Ingredient
IQ Formulations, of Sunrise, Florida is initiating a precautionary and proactive recall of all lots of its 45-capsule bottles of HYDRAVAX due to potential inclusion of an unlisted ingredient. The FDA has advised IQ Formulations that an analysis of a sample from one lot of HYDRAVAX (Lot # 2458, Exp # 07/16) revealed the presence of an undeclared ingredient – a diuretic.
FDA study helps provide an understanding of rising rates of whooping cough and response to vaccination
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.
Court order keeps food company from production until it cleans up
A Bakersfield, Calif., food company has agreed under terms of a court order not to process or distribute food until after it cleans up the unsanitary conditions found by U.S. Food and Drug Administration inspectors.
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.
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.