February 2010 - FDA News

FDA Approves Therapy to Treat Gaucher Disease The U.S. Food

FDA Approves Therapy to Treat Gaucher Disease
The U.S. Food and Drug Administration has approved velaglucerase alfa for injection (VPRIV) to treat children and adults with a form of the rare genetic disorder Gaucher disease.

FDA Approves Rituxan to Treat Chronic Lymphocytic Leukemia The U.S.

FDA Approves Rituxan to Treat Chronic Lymphocytic Leukemia
The U.S. Food and Drug Administration today approved Rituxan (rituximab) to treat certain patients with chronic lymphocytic leukemia (CLL), a slowly progressing blood and bone marrow cancer.

U.S. Attorney News Release: Medical Device Manufacturer Guidant Charged in

U.S. Attorney News Release: Medical Device Manufacturer Guidant Charged in Failure to Report Defibrillator Safety
U.S. Attorney News release: Medical Device Manufacturer Guidant Charged in Failure to Report Defibrillator Safety Problems to FDA

VIDAS fPSA rt Assay The VIDAS fPSA rt Assay is

VIDAS fPSA rt Assay
The VIDAS fPSA rt Assay is a lab tests, used along with digital rectal examination, to help diagnose prostate cancer in men age 50 years and older. (Approved: 10/8/2009)

Johnny's Fine Foods Recalls Johnny's French Dip Powdered Au Jus

Johnny's Fine Foods Recalls Johnny's French Dip Powdered Au Jus Because of Possible Health Risk
Johnny?s Fine Foods of Tacoma, Wash., Johnny?s Fine Foods is recalling French Dip Powdered Au Jus in 6oz bottles and French Dip Powdered Au Jus in 1.1oz foil packets, because it has the potential to be contaminated with Salmonella. Salmonella is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems...

Fresh & Easy Neighborhood Market Voluntarily Recalls Fresh & Easy Chewy Chocolate Chip Granola Bars Because of Possible Health Risk
Fresh & Easy Neighborhood Market Inc., is voluntarily recalling all date codes of fresh&easy? Chewy Chocolate Chip Granola Bars as a result of a recall initiated by Thumb Oilseed Producers. This company supplies an ingredient that has the potential to be contaminated with Salmonella.

FDA Approves Pneumococcal Disease Vaccine with Broader Protection The U.S.

FDA Approves Pneumococcal Disease Vaccine with Broader Protection
The U.S. Food and Drug Administration today approved Prevnar 13, a pneumococcal 13-valent conjugate vaccine for infants and young children ages 6 weeks through 5 years. Prevnar 13 will be the successor to Prevnar, the pneumococcal 7-valent conjugate vaccine licensed by the FDA in 2000 to prevent invasive pneumococcal disease (IPD) and otitis media. The new vaccine extends the protection to six additional types of the disease causing bacteria.

FDA Update on the Investigation into the Salmonella Montevideo Outbreak

FDA Update on the Investigation into the Salmonella Montevideo Outbreak - February 25, 2010
The Food and Drug Administration, along with the Centers for Disease Control and Prevention and the U.S. Department of Agriculture?s Food Safety and Inspection Service, continues to work closely with the Rhode Island Department of Health and other states in the investigation of an outbreak of Salmonella Montevideo infections associated with certain Italian-style sausage products including salami/salame.

NIH and FDA Announce Collaborative Initiative to Fast-track Innovations to

NIH and FDA Announce Collaborative Initiative to Fast-track Innovations to the Public
The U.S. Food and Drug Administration and the National Institutes of Health today unveiled an initiative designed to accelerate the process from scientific breakthrough to the availability of new, innovative medical therapies for patients.

VIDAS fPSA rt Assay The VIDAS fPSA rt Assay is

VIDAS fPSA rt Assay
The VIDAS fPSA rt Assay is a lab tests, used along with digital rectal examination, to help diagnose prostate cancer in men age 50 years and older. (Approved: 10/8/2009)

Estrella Family Creamery Expands Recall Of Various Cheeses Because Of

Estrella Family Creamery Expands Recall Of Various Cheeses Because Of Possible Health Risk
Estrella Family Creamery of Montesano, WA is recalling Brewleggio, Domino, and Wynoochee River Blue cheeses because they have 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.

Acacia, Inc. Announces Worldwide Voluntary Recall of IV Extension Sets with BD Q-Syte Luer Access Device
Acacia, Inc. (formally known as MPS Acacia) has voluntarily executed a product recall of certain lots of IV Extension Sets with BD Q-Syte Luer Access Device. The BD Q-Syte Luer Access Device is a Needleless Valve manufactured by BD (Becton, Dickinson and Company).

Pierino Frozen Foods Inc. Issues an Allergy Alert on Undeclared Eggs in Its Jumbo Shells with Cheese
Pierino Frozen Foods Inc. of Lincoln Park, Michigan is recalling its 24 oz. packages of Pierino Frozen Foods Jumbo Shells with Cheese because they contain undeclared eggs. People who have an allergy or severe sensitivity to eggs run the risk of serious or life-threatening allergic reaction if they consume these products.

U.S. Attorney News Release: Subject sentenced to 51 months for

U.S. Attorney News Release: Subject sentenced to 51 months for sale of unapproved medical devices
United States Attorney Karen P. Hewitt announced that James Folsom was sentenced today in federal court in San Diego to serve 51 months in custody and a $250,000 fine following his conviction on twenty-six felony counts relating to the sale of unapproved medical devices and the commission of offenses while on pretrial release. The Honorable John A. Houston, United States District Judge, also ordered the destruction of over 450 devices that had been seized by the government during the execution of a search warrant at a selfstorage unit used by the defendant. A federal jury found Folsom guilty of conspiring to ship adulterated and misbranded Rife-type biofrequency devices in interstate commerce, following a two-week trial in 2009.

FDA Warns about Serious Side Effects from Maalox Product Mix-Ups

FDA Warns about Serious Side Effects from Maalox Product Mix-Ups
The U.S. Food and Drug Administration today warned consumers about the potential for serious side effects from mistakenly using Maalox Total Relief instead of other Maalox products. The two products are intended for the relief of different symptoms and contain different active ingredients.

FDA Approves Rituxan to Treat Chronic Lymphocytic Leukemia The U.S.

FDA Approves Rituxan to Treat Chronic Lymphocytic Leukemia
The U.S. Food and Drug Administration today approved Rituxan (rituximab) to treat certain patients with chronic lymphocytic leukemia (CLL), a slowly progressing blood and bone marrow cancer.

FDA Approves Rituxan to Treat Chronic Lymphocytic Leukemia The U.S.

FDA Approves Rituxan to Treat Chronic Lymphocytic Leukemia
The U.S. Food and Drug Administration today approved Rituxan (rituximab) to treat certain patients with chronic lymphocytic leukemia (CLL), a slowly progressing blood and bone marrow cancer.

USDA and FDA Coordinating Efforts to Ensure Safety of Produce

USDA and FDA Coordinating Efforts to Ensure Safety of Produce
The U.S. Department of Agriculture (USDA) and the Food and Drug Administration are working together to achieve the goals of enhancing the safety and quality of fresh produce in ways that take into account the wide diversity of farming operations. We are committed to leveraging the expertise of our partner agencies and working together to ensure that our current produce safety and quality activities are complementary and consistent. While USDA?s Agricultural Marketing Service (AMS) is in the midst of evaluating a proposed marketing agreement for the leafy green industry, the FDA is currently developing a proposed produce safety regulation. It is our expectation that these products will take into account the diverse nature of farming operations and that any marketing agreement would conform to any regulations that may be promulgated by FDA.

DuraSeal Spine Sealant System The DuraSeal Spine Sealant System is

DuraSeal Spine Sealant System
The DuraSeal Spine Sealant System is used in spinal surgery and applied over sutures (stitches) to prevent cerebrospinal fluid (CSF) from leaking out of the incision site. (Approved: 9/4/2009)

Turkey Hill Dairy Issues Recall On Chocolate Marshmallow Ice Cream

Turkey Hill Dairy Issues Recall On Chocolate Marshmallow Ice Cream That May Contain Undeclared Treenuts (Almonds)
Turkey Hill Dairy of Conestoga, Pa., is recalling its 1.5 qt. (48 oz./1.42L) packages of Chocolate Marshmallow Premium Ice Cream because the product may contain almonds that were inadvertently added during production.

Trader Joe's Company Voluntarily Recalls Chocolate Chip Chewy Coated Granola Bars
February 10, 2010 - Trader Joe's Company of Monrovia, California is voluntarily recalling Trader Joe s Chocolate Chip Chewy Coated Granola Bars, UPC 82818, Use by Dates/Lot Codes 16JUL10H2 and 17JUL10H1, manufactured by Bloomfield Bakery, a subsidiary of Ralcorp Holdings, Inc. because it has the potential to 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.

FDA Warns about Serious Side Effects from Maalox Product Mix-Ups

FDA Warns about Serious Side Effects from Maalox Product Mix-Ups
The U.S. Food and Drug Administration today warned consumers about the potential for serious side effects from mistakenly using Maalox Total Relief instead of other Maalox products. The two products are intended for the relief of different symptoms and contain different active ingredients.

U.S. Attorney News Release: Company pleads guilty to felony misbranding

U.S. Attorney News Release: Company pleads guilty to felony misbranding of a drug
Grant C. Jaquith, Temporary Acting United States Attorney for the Northern District of New York, and Mark Dragonetti, Special Agent-in-Charge of the Food and Drug Administration, Office of Criminal Investigations, New York Field Office, announced that THE PLASTIC SURGERY GROUP, LLP (TPSG) of Albany, New York, was sentenced and ordered to pay restitution in the amount of $106,686, and a fine of $200,000, in connection with TPSG s plea of guilty to one felony count of misbranding drugs, in violation of Title 21, United States Code, Sections 331(k), 352(i)(3), and 333(a)(2). TPSG was sentenced in Federal District Court in Albany, New York by District Judge Thomas J. McAvoy.

FDA Unveils Initiative to Reduce Unnecessary Radiation Exposure from Medical

FDA Unveils Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging
The U.S. Food and Drug Administration today announced an initiative to reduce unnecessary radiation exposure from three types of medical imaging procedures: computed tomography (CT), nuclear medicine studies, and fluoroscopy. These procedures are the greatest contributors to total radiation exposure within the U.S. population and use much higher radiation doses than other radiographic procedures, such as standard X-rays, dental X-rays, and mammography.