American Regent is conducting a nationwide voluntary recall to the Retail/Hospital level of the following product: Phenylephrine HCl Injection, USP, 1% (10mg/mL), 5 mL Vial NDC # 0517-0405-25, Lot # 0693, Exp Date: October, 2012. PLEASE NOTE: This recall, initiated on February 22, 2012 to the Retail/Hospital Level, is for Lot # 0693 only.
Federal government gains permanent injunction against raw milk producer
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.
FDA acts to bolster supply of critically needed cancer drugs
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.
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.