FDA Approves Morphine Sulfate Oral Solution for Relief of Acute and Chronic Pain
The U.S. Food and Drug Administration today approved Morphine Sulfate Oral Solution for the relief of moderate to severe, acute and chronic pain in opioid-tolerant patients. This medicine will be available in 100 milligrams per 5 mL or 20 milligrams per 1 mL.

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Medtronic Melody Transcatheter Pulmonary Valve
The Medtronic Melody Transcatheter Pulmonary Valve is a manufactured replacement pulmonary heart valve that had already been previously repaired. The pulmonary valve is one of four valves in the human heart that help pump blood throughout the body. (Approved: 1/25/2010)

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FDA Announces Class I Recall of Certain Infusion Set Needles
The U.S. Food and Drug Administration today announced a Class I recall of Exel/Exelint Huber needles, Exel/Exelint Huber Infusion Sets and Exel/Exelint Securetouch+ Safety Huber Infusion Sets, manufactured by Nipro Medical Corporation for Exelint International Corporation.

Hettich Centrifuges with 2050 and 2076 Plastic Rotors: Recall
Plastic centrifuge rotor may crack, break apart and be forcefully ejected.

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FDA Approves New Drug for Rheumatoid Arthritis
The U.S. Food and Drug Administration approved Actemra (tocilizumab) on Friday to treat adults with moderate to severe rheumatoid arthritis who have not adequately responded to or cannot tolerate other approved drug classes for rheumatoid arthritis.

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FDA Updates Earlier Guidance on Respiratory Treatment Spiriva HandiHaler
The U.S. Food and Drug Administration today announced that data from a recent review of the Spiriva HandiHaler, a long-acting respiratory treatment for chronic obstructive pulmonary disease (COPD), do not support an increased risk of stroke, heart attack, or death in patients using the medicine.

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FDA Unveils First Phase of Transparency Initiative
The U.S. Food and Drug Administration today unveiled the first phase of its Transparency Initiative which is designed to explain agency operations, how it makes decisions, and the drug approval process. During an online presentation, the chair of the FDA s Transparency Task Force, Principal Deputy FDA Commissioner Joshua Sharfstein, described a Web-based curriculum called FDA Basics, aimed at helping the public better understand what the agency does. The curriculum is accessible via a link on the FDA Web site.

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FDA Approves First Percutaneous Heart Valve
The U.S. Food and Drug Administration today approved the Medtronic Melody Transcatheter Pulmonary Valve and Ensemble Delivery System, the first heart valve to be implanted through a catheter, or tube, in a leg vein and guided up to the heart. This new approach to the treatment of adults and children with previously implanted, poorly functioning pulmonary valve conduits can delay the need for open-heart surgery.

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FDA Health Alert for Merrick Beef Filet Squares Dog Treats Packaged and Distributed by Merrick Pet Care
The U. S. Food and Drug Administration is warning consumers not to use Merrick Beef Filet Squares for dogs distributed by Merrick Pet Care with a package date of Best By 111911 because the product may be contaminated with Salmonella.

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Sculptra Aesthetic
Sculptra Aesthetic is an implant of poly-L-lactic acid (PLLA) microparticles. It is injected into the facial tissue to correct shallow to deep smile lines (nasolabial fold) contour deficiencies and other facial wrinkles. (Approved: 7/28/2009)

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Limeno LLC. Recalls Rico Queso Duro Blanco (White Hard Cheese)
Limeno LLC. of Lake Worth, Florida, is recalling its 16 ounce packages of Rico Queso duro blanco (white hard cheese) distributed by Flores Food of America because they may have be contaminated with salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people and others with weakened immune systems. Healthy persons infected with salmonella often exparience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. in rare circumstances, infection with salmonella can result in the organism getting into the blood- stream and producing more severe illnesses such as arterial infections (i.e. infected aneurysms), endocarditis and arthritis.

Harry London Candies, Inc. announces a voluntary and limited recall of Harry London Chocolate Pecan Caramel Stars due to an undeclared allergen
January 4 2010 Harry London today announced it is voluntarily recalling 3310 individual units of the 4.62 ounce Harry London Chocolate Pecan Caramel Stars because they have not been labeled to include Wheat, FD&C colors Yellow #5, Red # 40 and Blue #1 as an ingredient.

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FDA Ends Maryland Seafood Processor?s Pattern of Sanitary Violations
The FDA today announced that a Maryland seafood processor delivering fresh, frozen, and ready-to-eat seafood in Virginia, Pennsylvania, and New Jersey, and Washington, D.C., is to stop processing and distributing adulterated fish and seafood because it is not compliant with federal food safety laws.

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FDA Schedules Public Meeting on Premarket Clearance Process for Medical Devices
The U.S. Food and Drug Administration announced today that it has scheduled a public meeting on Feb. 18, 2010, to discuss key challenges related to the premarket notification, or 510(k) process, used to review and clear certain medical devices marketed in the United States. The FDA receives more than 3,000 510(k) submissions each year.

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FDA Issues Consumer Alert on HAPPYTOT Stage 4 and Some HAPPYBABY Stage 1 & Stage 2 Baby Foods
The FDA is recommending that the public not consume any varieties of HAPPYTOT Stage 4 and certain varieties of HAPPYBABY Stage 1 and Stage 2 baby foods in pouches distributed by Nurture Inc. The firm is recalling these products because some pouches are leaking or swollen. Swollen or leaking pouches may indicate problems with the product, including possible contamination by bacteria that can cause illness, or that the packaging has been compromised and is at risk of bacterial contamination.

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CONSERVE Plus Total Resurfacing Hip System
The CONSERVE Plus Total Resurfacing Hip System is a metal on metal resurfacing artificial hip replacement system, surgically implanted to replace a hip joint. The CONSERVE Plus Total Resurfacing Hip System is called a resurfacing prosthesis because... (Approved: 11/3/2009)

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Nutty Guys Issues Public Notice on Voluntary Recall of Butter Toffee Peanuts and Yogurt Covered Peanuts
Public notice: Nutty Guys in cooperation with the U.S. Food and Drug Administration is issuing a voluntary recall of all Butter Toffee Peanuts and Yogurt Covered Peanuts with sell by dates before March 15th 2010.

The Wisconsin Cheeseman Recalls Cheese Logs/Cheese Balls
The Wisconsin Cheeseman announced today that it is recalling cheese log/cheese ball products in conjunction with the voluntary recall initiated by Parkers Farm, Inc. on January 15, 2010. Parkers Farm, Inc., located in Coon Rapids, Minnesota, believes some of its food items have the potential to be contaminated with Listeria monocytogenes bacteria

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FDA Warns Consumers about Counterfeit Alli
The U.S. Food and Drug Administration is today warning consumers about a counterfeit and potentially harmful version of Alli 60 mg capsules (120 count refill kit). Preliminary laboratory tests conducted by GlaxoSmithKline (GSK) the maker of the FDA approved over-the-counter weight-loss product revealed that the counterfeit version did not contain orlistat, the active ingredient in its product. Instead, the counterfeit product contained the controlled substance sibutramine. Sibutramine is a drug that should not be used in certain patient populations or without physician oversight. Sibutramine can also interact in a harmful way with other medications the consumer may be taking.

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FDA Issues Consumer Alert on HAPPYTOT Stage 4 and Some HAPPYBABY Stage 1 & Stage 2 Baby Foods
The FDA is recommending that the public not consume any varieties of HAPPYTOT Stage 4 and certain varieties of HAPPYBABY Stage 1 and Stage 2 baby foods in pouches distributed by Nurture Inc. The firm is recalling these products because some pouches are leaking or swollen. Swollen or leaking pouches may indicate problems with the product, including possible contamination by bacteria that can cause illness, or that the packaging has been compromised and is at risk of bacterial contamination.

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FDA Health Alert for Merrick Beef Filet Squares Dog Treats Packaged and Distributed by Merrick Pet Care
The U. S. Food and Drug Administration is warning consumers not to use Merrick Beef Filet Squares for dogs distributed by Merrick Pet Care with a package date of Best By 111911 because the product may be contaminated with Salmonella.

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U.S. Attorney News Release: Longmont, Colorado Man Arrested For Removing And Replacing Labels On Gatorade Bottles
Jason Eric Kay, age 38, of Longmont, Colorado, was arrested this afternoon without incident on charges of misbranding and altering food labels with intent to cause serious injury to the business of any person, the U.S. Attorney s Office and the Food and Drug Administration Office of Criminal Investigations (FDA OCI) announced. Kay will be held overnight in custody.

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FDA Awards Contract to Harvard Pilgrim to Develop Pilot for Safety Monitoring System
The U.S. Food and Drug Administration has awarded a contract to Harvard Pilgrim Health Care Inc. to develop a pilot of the FDA s Sentinel System, which will use automated health care data to evaluate medical product safety.

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