The U.S. Food and Drug Administration today approved the first FDA-approved HPV DNA test for women 25 and older that can be used alone to help a health care professional assess the need for a woman to undergo additional diagnostic testing for cervical cancer. The test also can provide information about the patient’s risk for developing cervical cancer in the future.
FDA proposes to extend its tobacco authority to additional tobacco products, including e-cigarettes
As part of its implementation of the Family Smoking Prevention and Tobacco Control Act signed by the President in 2009, the U.S. Food and Drug Administration today proposed a new rule that would extend the agency’s tobacco authority to cover additional tobacco products.
FDA approves Sylvant for rare Castleman’s disease
The U.S. Food and Drug Administration today approved Sylvant (siltuximab) to treat patients with multicentric Castleman’s disease (MCD), a rare disorder similar to lymphoma (cancer of the lymph nodes).
Miravalle Foods, Inc. Recalls Ground Annato Because of Possible Health Risk
Miravalle Foods, Inc. of El Monte, CA, is conducting a voluntarily recall on its 0.75 ounce packages of Miravalle brand Achiote Molido Ground Annato spice because they have the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain.
Nano Well-being Health Inc. Issues Voluntary Nationwide Recall of Super Arthgold Due to Undeclared Ingredients
La Mirada, CA, Nano Well-being Health Inc. is voluntarily recalling lot L1P1-6100/Expiration date June 25, 2016 and lot L1P2-6000/Expiration date September 16, 2016 of Super Arthgold, 500 mg capsules to the consumer level. FDA laboratory analysis has found the product to contain chlorzoxazone, diclofenac and indomethacin, making it an unapproved new drug.
FDA proposes new expedited access program for medical devices that address unmet medical needs
Today, the U.S. Food and Drug Administration proposed a new program to provide earlier access to high-risk medical devices that are intended to treat or diagnose patients with serious conditions whose medical needs are unmet by current technology.
Dominex Natural Foods, LLC, Issues Voluntary Recall Due to Possible Undeclared Nut Allergen in AngelBowls brand of Corkscrew Pasta & Creamy Tomato Vodka Sauce Pasta Bowl
Dominex Natural Foods, LLC, is voluntarily recalling its AngelBowls Corkscrew Pasta and Creamy Tomato Vodka Sauce with following day codes: 00914 and 01314; (“Corkscrew Pasta”) because its ingredients may include undeclared pine nuts, a potential allergen. The company has determined that a small number of cases were inadvertently mispackaged.
Hospira Announces Voluntary Nationwide Recall of One Lot of 0.25% Marcaine™ (Bupivacaine HCI Injection, USP), 10 ml, Single-Dose, Preservative-Free Vial Due to Visible Particulates
Hospira, Inc. (NYSE: HSP), announced today it will initiate a voluntary nationwide recall to the user level for one lot of 0.25% Marcaine™ (Bupivacaine HCl Injection, USP), 10 mL, Single-dose Vial – Preservative Free (NDC 0409-1559-10), Lot 34-440-DD. The recall is due to a confirmed customer report of discolored solution with visible particles embedded in the glass as well as discolored solution.
FDA approves Cyramza for stomach cancer
The U.S. Food and Drug Administration today approved Cyramza (ramucirumab) to treat patients with advanced stomach cancer or gastroesophageal junction adenocarcinoma, a form of cancer located in the region where the esophagus joins the stomach.
Wegmans Food Markets, Inc. Issues Allergy Alert on Undeclared Egg in Wegmans Easter Bread, 17 oz.
Wegmans Food Markets, Inc. has initiated a voluntary recall of all Wegmans Easter Bread (braided loaf) 17 oz., UPC 77890 32431 (all code dates) because it contains egg, which is not declared on the label. People who have an allergy or severe sensitivity to egg run the risk of serious or life-threatening allergic reaction if they consume this product.