22/02/2012 In Uncategorized by Food and Drug Administration--Press Releases
A federal court has granted the U.S. Food and Drug Administration a permanent injunction preventing Daniel L. Allgyer and his Rainbow Acres Farm from distributing raw milk and raw milk products in final package form for human consumption across state lines.
22/02/2012 In Uncategorized by Food and Drug Administration--Recalls/Safety Alerts
Healthy People Co. announced today that is expanding its voluntary nationwide recall of the company’s dietary supplements sold under the brand names described below, regardless of the lot numbers referenced herein, and to the extent these products were bought on or before October 25, 2011. On February 02, 2011, Healthy People Co. conducted a voluntary recall because FDA lab analysis confirmed the presence of Sibutramine and Tadalafil in the products identified herein, making the following products unapproved new drugs:
21/02/2012 In Uncategorized by Food and Drug Administration--Press Releases
The U.S. Food and Drug Administration today announced a series of steps to increase the supply of critically needed cancer drugs and build on President Obama’s Executive Order to help prevent future drug shortages.
17/02/2012 In Uncategorized by Food and Drug Administration--Press Releases
Today, Korlym (mifepristone) was approved by the U.S. Food and Drug Administration to control high blood sugar levels (hyperglycemia) in adults with endogenous Cushing’s syndrome. This drug was approved for use in patients with endogenous Cushing’s syndrome who have type 2 diabetes or glucose intolerance and are not candidates for surgery or who have not responded to prior surgery. Korlym should never be used (contraindicated) by pregnant women.
17/02/2012 In Uncategorized by Food and Drug Administration--Recalls/Safety Alerts
McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc. (McNeil), is voluntarily recalling, at the wholesale and retail levels, seven lots, approximately 574,000 bottles, of Infants TYLENOL Oral Suspension, 1 oz. Grape distributed nationwide in the United States (see full product list below). Infants TYLENOL is an over-the-counter (OTC) product indicated as a pain reliever/fever reducer.
14/02/2012 In Uncategorized by Food and Drug Administration--Press Releases
On February 10, the U.S. Food and Drug Administration approved Zioptan (tafluprost ophthalmic solution) to help reduce elevated eye pressure in people with open-angle glaucoma.
14/02/2012 In Uncategorized by Food and Drug Administration--Recalls/Safety Alerts
Flight Medical Innovations Ltd. (Flight Medical) issued the following update regarding its voluntary recall of remote alarm cable, part number V24-00400-29, used to connect a Newport HT50 mechanical ventilator to a nurse station. The recalled cable may negatively affect Newport HT50 ventilators manufactured prior to 2007.
13/02/2012 In Uncategorized by Food and Drug Administration--Press Releases
The U.S. Food and Drug Administration is requesting a budget of $4.5 billion to protect and promote the public health as part of the President’s fiscal year (FY) 2013 budget – a 17 percent increase over the FDA enacted budget for FY 2012. Industry user fees would fund 98 percent of the proposed budget increase. The FY 2013 request covers the period from Oct. 1, 2012 through Sept 30, 2013.
13/02/2012 In Uncategorized by Food and Drug Administration--Press Releases
Accurate Set Inc., of Newark, N.J., and the company’s president and owner, Cornell L. Adams, have agreed to stop manufacturing and distributing medical devices as part of a consent decree of permanent injunction.
12/02/2012 In Uncategorized by Food and Drug Administration--Recalls/Safety Alerts
Walmart recalled its eight-count packages of Cruller bakery pastries because the common name of milk was not listed following sodium caseinate, a milk derivative, on the ingredient label. People who have milk allergies that do not recognize sodium caseinate as a milk derivative run the risk of serious or life-threatening allergic reactions if they consume the product.