The United States Attorney’s Office, at the request of the U.S. Food and Drug Administration, filed a verified complaint on May 13, 2011, requesting that the U.S. Marshals seize cheese products distributed by Brunkow Cheese of Wisconsin Inc., after FDA inspections found evidence of rodent infestation. The U.S. District Court unsealed the case today, and documents show that the U.S. Marshals seized certain cheese products at the facility on May 17, and May 18, 2011.
Category Archives: Drug Recalls & Safety Notices
FDA clears first test for recent infection with toxoplasmosis parasite
On May 18, the U.S. Food and Drug Administration cleared the first test to help determine whether a pregnant woman or a person with swollen lymph nodes testing positive for toxoplasmosis, sometimes known as cat scratch disease, developed the infection within the past four months.
FDA approves Victrelis for Hepatitis C
The U.S. Food and Drug Administration today approved Victrelis (boceprevir) to treat certain adults with chronic hepatitis C. Victrelis is used for patients who still have some liver function, and who either have not been previously treated with drug therapy for their hepatitis C or who have failed such treatment. Victrelis is approved for use in combination with peginterferon alfa and ribavirin.
FDA warns about counterfeit ExtenZe dietary supplements
The U.S. Food and Drug Administration is warning consumers about a counterfeit product represented as “ExtenZe,” which is the name of an authentic dietary supplement for male sexual enhancement.
FDA: Don’t buy drugs marketed as antimicrobial dietary supplements
The FDA is warning consumers not to use products marketed as dietary supplements that also claim to be antimicrobial (antibiotic, antifungal or antiviral) drugs. These illegal products are falsely promoted with claims to treat illnesses such as upper respiratory infections, sinusitis, pneumonia, bronchitis and the common cold
FDA: No compre medicamentos comercializados como suplementos nutricionales antimicrobianos
La Administración de Alimentos y Medicamentos (FDA por sus siglas en inglés) les está advirtiendo a los consumidores que no usen productos comercializados como suplementos nutricionales que también afirman ser medicamentos antimicrobianos (antibióticos, antifúngicos o antivirales). Estos productos ilegales se promueven falsamente con afirmaciones de que curan enfermedades como infecciones del sistema respiratorio superior, sinusitis, pulmonía, bronquitis y resfrío común.
FDA seeks permanent injunction against Tennessee food warehouses, owner
The U.S. Food and Drug Administration today requested a permanent injunction against American Mercantile Corp., Ingredients Corporation of America, and Damon S. Arney, owner and president of the companies. The companies receive, process, manufacture, prepare, pack, label, hold, and distribute a wide variety of food products and ingredients, including spices, herbs, and sauces.
FDA requests input on development of user fee program for biosimilar and interchangeable biological products
The U.S. Food and Drug Administration is requesting input from stakeholders and the public relating to the development of a user fee program for biosimilar and interchangeable biological product (351(k)) applications.
Consumers warned to avoid eating oysters from area 1642 in Apalachicola Bay, Florida
The U.S. Food and Drug Administration is advising consumers, restaurant operators, commercial shippers and processors of shellfish not to eat, serve, purchase, sell or ship oysters from Area 1642 in Apalachicola Bay, Fla. because the oysters may be contaminated with toxigenic Vibrio cholerae serogroup O75.
FDA expands approved use for carotid stent
The U.S. Food and Drug Administration today approved an expanded indication that will allow a new group of patients at risk of stroke due to clogged neck arteries to be treated with the RX Acculink carotid stent.