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.
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Healthy People Co. is Expanding its Voluntary Recall Initiated on February 02, 2012 to Include Dietary Products Bought on or Before October 25, 2011
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:
FDA approves Korlym for patients with endogenous Cushing’s syndrome
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.
McNeil Consumer Healthcare Announces Voluntary Nationwide Recall of Infants’ TYLENOL® Oral Suspension, 1 oz. Grape Due to Dosing System Complaints
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.
FDA approves Zioptan to treat elevated eye pressure
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.
Flight Medical Innovations Ltd. Provides Update on Recall of Ventilator Remote Alarm Cable
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.
FDA seeks $4.5 billion to support medical product development, protect patients and ensure safety of the food supply
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.
New Jersey company agrees to halt production of unapproved dental devices
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.
Walmart Recalls Cruller Bakery Pastries Due To Mislabeled Milk Allergen
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.
Regeneca, Inc. Issues A Voluntary Nationwide Recall Of A Specific Lot Of RegenArouse Because Of Potential Health Risks
Regeneca, Inc. announced today that it is conducting a voluntary nationwide recall of RegenArouse, Lot Number 130100, because FDA lab analysis has confirmed the presence of Tadalafil making these products unapproved new drugs. Tadalafil is an FDA-approved drug used as treatment for male Erectile Dysfunction (ED). The active drug ingredient is not listed on the label for these products.