As previously reported, on July 1, 2014, biological samples were found in the cold storage area of U.S. Food and Drug Administration laboratories on the National Institutes of Health campus. The FDA has since acquired additional information from the federal investigative agencies regarding inventories of the materials.
Category Archives: Food Safety News
Charles Products Recalls Decorative Pint And Shot Glasses Due To Possible Health Risk
Charles Products, Inc. (CPI) announced today that it is voluntarily recalling shot and pint glasses identified below sold exclusively through M&M’S World retail stores in New York, Las Vegas, Orlando and London.
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United States enters consent decree with New York dietary supplement manufacturer
Triceutical, Inc., of Farmingdale, New York, and Liqun Zhang, the company’s president, have agreed to stop production and distribution of dietary supplements under the terms of a consent decree because of violations of federal dietary supplement regulations, known as Current Good Manufacturing Practice (cGMP) requirements.
FDA approves Beleodaq to treat rare, aggressive form of non-Hodgkin lymphoma
The U.S. Food and Drug Administration today approved Beleodaq (belinostat) for the treatment of patients with peripheral T-cell lymphoma (PTCL), a rare and fast-growing type of non-Hodgkin lymphoma (NHL). The action was taken under the agency’s accelerated approval program.
Federal judge approves consent decree with New York dietary supplement maker
A federal judge in New York has signed a consent decree for permanent injunction between the United States and Mira Health Products Ltd., a dietary supplement manufacturer located in Farmingdale, New York, and Michael S. Ragno and Michael S. Ragno, Jr.
FDA seeks permanent injunction against California pharmaceutical company
On June 25, the U.S. Department of Justice, at the request of the U.S. Food and Drug Administration, filed a complaint for permanent injunction in the U.S. District Court for the Central District of California against Laclede, Inc. (Laclede) of Rancho Dominguez, California, and its president, Michael A. Pellico. The complaint claims that Laclede illegally distributes over-the-counter vaginal drug products without required FDA approval.
Flowers Foods Issues Allergy Alert and Voluntary Recall on Limited Quantity of Sunbeam, Bunny, Flowers Deli, and Ingles Bar-B-Q Bread Sold in Alabama, Georgia, Louisiana, and Tennessee
Flowers Foods (NYSE: FLO) is voluntarily recalling the following brands of Bar-B-Q bread because they may contain undeclared milk. People who have allergies to dairy products run the risk of serious or life-threatening allergic reaction if they consume these products. No illnesses have been reported to date.
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FDA outlines expectations for human drug compounders, including registered outsourcing facilities
Today, the U.S. Food and Drug Administration issued several policy documents regarding compounded drug products for human use, as part of the agency’s continuing effort to implement the compounding provisions of the Drug Quality and Security Act (DQSA), enacted in November 2013. The policy documents consist of a draft interim guidance, a proposed rule, a final guidance, and two revised requests for nominations for the bulk drug substances lists.
FDA approves Afrezza to treat diabetes
The U.S. Food and Drug Administration today approved Afrezza (insulin human) Inhalation Powder, a rapid-acting inhaled insulin to improve glycemic control in adults with diabetes mellitus. Afrezza is a rapid-acting inhaled insulin that is administered at the beginning of each meal, or within 20 minutes after starting a meal.
FDA allows marketing of first wearable, motorized device that helps people with certain spinal cord injuries to walk
The U.S. Food and Drug Administration today allowed marketing of the first motorized device intended to act as an exoskeleton for people with lower body paralysis (paraplegia) due to a spinal cord injury. ReWalk is a motorized device worn over the legs and part of the upper body that helps an individual sit, stand, and walk with assistance from a trained companion, such as a spouse or home health aide.