The U.S. Food and Drug Administration today approved Dificid (fidaxomicin) tablets for the treatment of Clostridium difficile-associated diarrhea (CDAD).
Category Archives: Food & Drug Recalls
FDA approves injectable gel to treat fecal incontinence
The U.S. Food and Drug Administration today approved a sterile, injectable gel to treat fecal incontinence in patients for whom other therapies such as diet change, fiber therapy or anti-motility medications failed.
Transpecos Foods, LP Issues Allergy Alert On Undeclared Milk And/Or Egg Allergen In Onion Ring Product
Transpecos Foods, LP of Pecos, Texas is recalling the following items because they may contain undeclared Milk and/or Egg allergens: Southern Home Diced Onion Rings, Net WT 20 oz (1 LB 4 OZ) 567 g, UPC 60788001108, sold prior to 5/27/2011, packaged in a printed bag was distributed in South Carolina, Georgia, and Pennsylvania.
FDA seeks comment on preventive controls against foodborne illness
The Food and Drug Administration is seeking public comment on preventive control measures for food facilities through a public docket opened this week as part of the FDA Food Safety Modernization Act (FSMA), signed into law by President Obama in January.
FDA to make enforcement and compliance activities accessible online
The U.S. Food and Drug Administration today announced that it is disclosing more information about inspections and court actions, and now has a web portal on its enforcement activities as part of Phase II of the agency’s Transparency Initiative. These actions are being taken to make FDA’s enforcement and compliance-related activities more accessible, downloadable, and searchable online.
FDA takes action against illegal marketing of tobacco products
The U.S. Food and Drug Administration today announced it issued 11 warning letters last week to online retailers for illegally marketing tobacco products with misleading or unsubstantiated claims or descriptors indicating that they can be used to reduce harm or the risk of tobacco-related disease.
BCS International Corp. Issues Allergy Alert On Undeclared Peanuts In Dr. Snack Choco Raisin With Sell By Date 03/05/2012
BCS Int’l Corp. of Long Island City, NY is voluntarily recalling DR. SNACK brand CHOCO RAISIN, 12 OZ. containers with “Sell By 03/05/2012” date code only because they may contain undeclared peanuts. People who have an allergy to peanuts run the risk of serious or life-threatening allergic reaction if they consume this product.
Globe All Wellness, LLC Issues a Voluntary Recall of Dietary Supplement Found to Contain an Undeclared Drug Ingredient
Globe All Wellness, LLC has been informed by the Food and Drug Administration (FDA) that one of the company’s weight loss dietary supplements that was sold by a seller that was not authorized by Globe All Wellness, LLC to sell the product contains an undeclared drug ingredient. FDA lab analyses of this dietary supplement was found to contain undeclared Sibutramine. The FDA has not approved Sibutramine; therefore the safety and effectiveness of this product is unknown.
Undeclared Eggs in “Halal Plain” & “Halal Fruit Cake”
New York State Agriculture Commissioner Darrel J. Aubertine today alerted consumers to undeclared eggs in “Halal Plain Cake” and “Halal Fruit Cake”, packaged and distributed by Narala Bakery Inc. of 744 Coney Island Avenue, Brooklyn, New York. People who have severe sensitivity to eggs may run the risk of serious or life-threatening reactions if they consume this product.
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FDA approves Incivek for hepatitis C
The U.S. Food and Drug Administration today approved Incivek (telaprevir) to treat certain adults with chronic hepatitis C infection. Incivek is used for patients who have either not received interferon-based drug therapy for their infection or who have not responded adequately to prior therapies. Incivek is approved for use with interferon therapy made up of peginterferon alfa and ribavirin.