ConvaTec has announced that the U.S. Food and Drug Administration (FDA) has classified the company’s recently initiated voluntary global recall of Flexi-Seal™ CONTROL Fecal Management System (FMS) as a Class I recall.
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.
Cargill Conducts Voluntary Recall of Select Nutrena® NatureWise® Meatbird Feed Due to Possible Animal Health Risk
Minneapolis, Minn., – 1 July 2014 – Cargill’s animal nutrition business today announced a voluntary recall of its Nutrena NatureWise meatbird feed due to excess levels of sodium. Sodium is an essential nutrient for poultry.
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.
Oriya Organics, LLC Voluntarily Recalls Oriya Organics Superfood Protein Medley Containing Sprouted Chia Seed Powder for Possible Salmonella Contamination
Oriya Organics, LLC is voluntarily recalling Oriya Organics Superfood Protein Medley which contain Organic Sprouted Chia Seed Powder due to possible health risks related to Salmonella contamination.
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.
Richard’s Rubs & Seasonings Recalls Sauces Because of Possible Health Risk
Richard’s Rubs & Seasonings LLC is recalling Richard’s Too Good BBQ Sauce, Richard’s Too Good Hot Sauce and Richard’s Too Good Teriyaki Sauce because they may have been improperly processed and because they may have the potential to be contaminated with Clostridium botulinum, which can cause botulism, a serious and potentially fatal foodborne illness.
Nestlé USA Issues Recall Of Limited Amounts Of Häagen-Dazs® Chocolate Chocolate Chip Ice Cream In East Coast Region Due To Mismatched Packaging
Nestlé USA is initiating a recall of limited amounts of ice cream due to mismatched packaging. The affected products are 14-ounce cartons labeled as Häagen-Dazs Chocolate Chocolate Chip Ice Cream with a UPC of 74570-08400, and lid labeled as Häagen-Dazs Chocolate Peanut Butter.