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.
FDA: Do not feed SimplyThick to premature infants
The FDA is advising parents, caregivers and health care providers not to feed SimplyThick, a thickening product, to premature infants. The product may cause necrotizing enterocolitis (NEC), a life-threatening condition.
FDA approves Sutent for rare type of pancreatic cancer
The U.S. Food and Drug Administration today approved Sutent (sunitinib) to treat patients with progressive neuroendocrine cancerous tumors located in the pancreas that cannot be removed by surgery or that have spread to other parts of the body (metastatic).
United States requests seizure of adulterated cheese products at Wisconsin company
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.
FDA clears first test to diagnose Q fever in military serving overseas
The U.S. Food and Drug Administration today cleared the first nucleic acid amplification test to diagnose the early stages of Q fever infections in military personnel serving overseas. The Chemical Biological Medical System Joint Project Management Office within the U.S. Department of Defense funded the development of this test, which identifies and detects the bacteria that cause Q fever (Coxiella burnetii) within four hours. The test was developed by Idaho Technology Inc.
FDA approves new HIV treatment
The U.S. Food and Drug Administration today approved Edurant (rilpivirine) in combination with other antiretroviral drugs for the treatment of HIV-1 infection in adults who have never taken HIV therapy (treatment-naïve).
Recall of Infant and Neonatal-Sized FilterLine H Set and VitaLine H Set Sampling Lines
Philips recently recalled specific lots of infant and neonatal-sized Philips FilterLine H Set and VitaLine H Set Microstream carbon dioxide (CO2) sampling lines shipped from November 2010 through March 2011. Philips initiated the recall in April 2011 after being informed by the manufacturer of these devices, Oridion Systems Ltd., that due to a production issue affecting certain lots, it was recalling these products, which it also markets under its own name.
Atalanta Corp. Recalls “Nazareth Classic and Nazareth Light Cheeses” Because of Possible Health Risk
“Nazareth Classic” and “Nazareth Light” cheese has been recalled by Atalanta Corporation, an Elizabeth, New Jersey based food distributor, because the product has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.
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American Regent Initiates Nationwide Voluntary Recall of Sterile Water for Injection, USP 50 mL Single Dose Vial Due to Particulate Matter
American Regent is conducting a nationwide voluntary recall to the
consumer and user level of the following product:
Sterile Water for Injection, USP, 50 mL Single Dose Vial,
NDC # 0517-3050-25, Lot 0092, Exp. Date February, 2014
PLEASE NOTE: This recall, initiated on May 19, 2011 to the User or Consumer Level, is for Lot 0092 Only.
Phoenix Import & Distribution Announces A Recall Of Pentrexyl Forte Natural
Phoenix Import & Distribution LLC is issuing a voluntary recall for PENTREXYL FORTE NATURAL because the packaging is believed to be misleading, causing it to be confused with an antibiotic. The product is packaged in a green and white box, containing 30 red and white capsules.
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