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.
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.