The U.S. Food and Drug Administration today cleared a test called the Cepheid Xpert C. difficile/Epi assay that is designed to rapidly detect the toxin B gene associated with Clostridium difficile infection (CDI), a cause of diarrhea that can lead to colitis, other serious intestinal conditions and death in severe cases.
Tri-Union Seafoods Issues Precautionary, Voluntary Recall Of Limited 6.5-Ounce Chopped Clams
Tri-Union Seafoods LLC is issuing a precautionary, voluntary recall of a limited amount of Chicken of the Sea brand 6.5-ounce chopped clams. The product is mislabeled and may contain tiny shrimp, and the company is conducting this precautionary, voluntary recall to ensure public health as shellfish is considered an allergen.
FDA approves Horizant to treat restless legs syndrome
On April 6, the U.S. Food and Drug Administration approved Horizant Extended Release Tablets (gabapentin enacarbil), a once-daily treatment for moderate-to-severe restless legs syndrome (RLS).
FDA approves new treatment for rare form of thyroid cancer
medullary, thyroid cancer
FDA approves new device to treat brain aneurysms
The U.S. Food and Drug Administration today approved a new device that provides neurointerventional surgeons with another tool to treat brain aneurysms without performing open surgery.
FDA acts to prevent contamination problems with Triad antiseptic products
U.S. Marshals seize drug products manufactured and distributed by Wisconsin firms
Le Bon Patissiere-2, Inc. Announces Voluntary Recall On Select Le Bon Patissiere Products That Contain Undeclared Allergens
Le Bon Patissier of La Crescenta, CA is conducting a voluntary recall on the following Le Bon Patissier Products because they contain undeclared allergens. People who have an allergen or severe sensitivity to wheat, egg, pistachios, walnuts, or milk run the risk of serious or life-threatening allergic reaction if they consume these products.
Fresh Express Announces Precautionary Recall of a Limited Number of Cases of 9 oz. Bag Spinach Due to Possible Health Risk from Salmonella
resh Express is voluntarily recalling 2,939 cases of 9 oz. Bag Spinach with Product Codes starting with H081 and H082, UPC Code of 7127913204 and Use-by Dates of April 6 and 7 out of an abundance of caution due to a positive test result for Salmonella from random sample testing.
FDA launches consumer-friendly Web search for consumers during recalls
Beginning today, consumers can search for food and other product recalls easier and quicker on FDA’s website than previously. The FDA Food Safety Modernization Act (FSMA) signed into law in January by President Obama called for a more consumer-friendly recall search engine. DSK
AVNS, Inc. Issues a Voluntary Recall of THE BEST Enhancer
AVNS Inc announced today it is voluntarily recalling THE BEST Enhancement Supplement. AVNS Inc is conducting a voluntary recall after being informed by their manufacturer, Drive Total Energy, that the Food and Drug Administration (FDA) lab analyses found that the products to contain Sulfoaildenafil, an analogue of Sildenafil, an FDA-approved drug used in the treatment of male Erectile Dysfunction (ED), making these products unapproved new drugs.