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NEWS: U.S. Food and Drug Administration (FDA)

FDA Approves Vaccines for the 2010-2011 Influenza Season

FDA: Press Releases - 1 hour 42 min ago
The U.S. Food and Drug Administration announced today that it has approved vaccines for the 2010-2011 influenza season in the United States.

FDA Statement on the Reopening of Some La. State Waters to Commercial Fishing

FDA: Press Releases - 4 hours 31 min ago
STATEMENT BY MARGARET A. HAMBURG, COMMISSIONER OF FOOD AND DRUGS, ON THE REOPENING OF SOME LOUISIANA STATE WATERS TO COMMERCIAL FISHING (HR)

Nutraloid Labs Inc. Conducts Voluntary Nationwide Recall of Two Dietary Supplements Found to Contain Undeclared Drug Ingredient

FDA: Recalls - Thu, 07/29/2010 - 18:43
Nutraloid Labs Inc. announced today that it is conducting a voluntary nationwide recall of two dietary supplement products sold under the names: ejaculoid XXTREME and stimuloid II. Nutraloid Labs Inc. has been informed by representatives of the Food and Drug Administration (FDA) that lab analysis of ejaculoid XXTREME, Lot 79935, and stimuloid II, Lot 79936, by the FDA found that the products contain sulfoaildenafil, similar in structure to Sildenafil.

Specialty Farms, LLC Expands Recall of Organic Alfalfa Sprouts Blend and Organic Sprout Salad in the North Eastern United States Because of Possible Health Risk

FDA: Recalls - Thu, 07/29/2010 - 16:40
Specialty Farms is voluntarily recalling certain Alfalfa sprout products with a best if sold by date of “8/3/2010” and “8/1/2010” that has the potential to be contaminated with Listeria Monocytogenes (LM). Listeria Monocytogenes is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

Evamist (estradiol transdermal spray): Drug Safety Communication - Unintended Exposure of Children and Pets to Topical Estrogen

FDA: Medical Watch - Thu, 07/29/2010 - 13:00
Reports of adverse effects in children who may have been unintentionally exposed to the drug through skin contact with women using this product.

FDA Advisory: Avoid Unintentional Exposure of Children and Pets to Evamist

FDA: Press Releases - Thu, 07/29/2010 - 12:59
The U.S. Food and Drug Administration is warning that inadvertent exposure to Evamist through skin contact with patients using this product has the potential for adverse effects in children and pets.

Former CEO of Seafood Importing Corporation Sentenced to Federal Prison for Importing Falsely Labeled Fish

FDA: Press Releases - Thu, 07/29/2010 - 10:43
Former CEO of Seafood Importing Corporation Sentenced to Federal Prison for Importing Falsely Labeled Fish

Cubicin (daptomycin): Drug Safety Communication - Risk of Eosinophilic Pneumonia

FDA: Medical Watch - Thu, 07/29/2010 - 09:00
Cases of serious, potentially fatal pneumonia associated with the IV antibacterial drug Cubicin.

Consumer Information on: OraQuick HCV Rapid Antibody Test - P080027

The OraQuick HCV Rapid Antibody Test is used to detect a patient?s exposure to the hepatitis C virus (HCV). Antibodies are proteins produced by the body to fight against foreign substances, such as viruses and bacteria. The presence of the antibodies...

Dulcería Chepito Emite una Alerta por Alergenos en Sus Productos "Almejas"

FDA: Recalls - Wed, 07/28/2010 - 15:11
Dulcería Chepito localizada en Cabo Rojo, PR está llevando a cabo un recogido voluntario del producto "Chepito Dulces Tropicales - Almejas" empacados en unidades de 6 oz. Este producto contiene huevos y no está declarado en la etiqueta. Personas que son alérgicas al huevo están en riesgo de serias reacciones alérgicas si consumen estos productos.

FDA Approves Drug for Chronic Drooling in Children

FDA: Press Releases - Wed, 07/28/2010 - 14:58
The U.S. Food and Drug Administration today approved Cuvposa (glycopyrrolate) Oral Solution to treat chronic severe drooling caused by neurologic disorders in children ages 3 years to 16 years.

New Early Detection System Helps FDA Identify More than 100 Food Safety Problems in First 7 Months

FDA: Press Releases - Wed, 07/28/2010 - 11:01
More than 100 food safety reports were submitted by industry to the U.S. Food and Drug Administration’s new electronic portal in its first months of operation, the agency said today.

Biggers & Callaham, LLC DBA Mice Direct Recalls Frozen Reptile Feed Because of Possible Health Risk

FDA: Recalls - Wed, 07/28/2010 - 10:44
Biggers & Callaham LLC., D/B/A Mice Direct of Cleveland Georgia is recalling frozen reptile feed (mice, rats, chicks), because it has the potential to be contaminated with Salmonella . Salmonella can affect animals and there is risk to humans from handling contaminated pet products.

Voluntary Recall of PreserVision® Eye Vitamin AREDS 2 Formula in the United States

FDA: Recalls - Tue, 07/27/2010 - 16:37
Bausch + Lomb is conducting a voluntary recall of its PreserVision® Eye Vitamin AREDS 2 Formula with Omega 3 soft gels, only available within the United States. Bausch + Lomb chose to initiate this recall based on a small number of reports predominantly within a specific age group, age 70 and older, who reported difficulty swallowing or a choking sensation when taking the soft gel.

Federal Agents Seize FastSize Extenders and FastSize EQM Erectile Quality Monitors

FDA: Press Releases - Tue, 07/27/2010 - 15:57
At the request of the U.S. Food and Drug Administration, U.S. Marshals today seized $346,954.43 worth of FastSize Extender devices and FastSize EQM Erectile Quality Monitor devices, as well as component parts used in the manufacture of the FastSize Extender. The FastSize Extender and the FastSize EQM Erectile Quality Monitor are manufactured and distributed by FastSize, LLC of Aliso Viejo, Calif.

P&G Recalls Two Lots of Prescription Renal Diet Cat Food due to a Possible Health Risk

FDA: Recalls - Tue, 07/27/2010 - 12:13
The Procter & Gamble Company (P&G) (NYSE:PG), is voluntarily recalling two specific lots of its prescription renal dry cat food as a precautionary measure, as it has the potential to be contaminated with salmonella. The following products are included...

Pennsylvania Dairy Farm Agrees to Stop Improper Medication

FDA: Press Releases - Tue, 07/27/2010 - 10:43
Owners agree to keep illegal drug residues out of animals sold for human consumption A Pennsylvania dairy farm has agreed to abide by federal regulations that protect meat from illegal drug residues caused by the unapproved medication of cattle before slaughter, as part of a consent decree of permanent injunction obtained by the U.S. Food and Drug Administration.

Airgas South Initiates Precautionary Voluntary Recall of Medical Gas Products at Chattanooga, TN Facility

FDA: Recalls - Mon, 07/26/2010 - 21:44
Airgas South, Inc., a distributor of industrial, medical, and specialty gases, today announced an expanded voluntary recall of medical gas products filled at its Chattanooga, Tennessee facility. The recall is being initiated as a precautionary measure because these products may have been manufactured under conditions that did not sufficiently comply with current Good Manufacturing Practices (cGMPs). These practices help assure that drug products meet required quality standards for quality, purity and potency.

Pasco Processing LLC, Announces Voluntary Product Recall Because of Possible Health Risk

FDA: Recalls - Sun, 07/25/2010 - 09:57
Pasco Processing, LLC, Pasco WA is recalling 2087 cases of 20lb. bulk packaged Corn and Poblano peppers, (SKU 10071179017738) because of 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. Healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea...

Specialty Farms, LLC Recalls Organic Alfalfa Sprouts Blend and Organic Sprout Salad in the North Eastern United States Because of Possible Health Risk

FDA: Recalls - Sun, 07/25/2010 - 09:55
Specialty-Farms, LLC is voluntarily recalling Specialty Farms brand Organic Alfalfa Sprouts Blend and Organic Sprout Salad, as noted below. These items both have a "sell-by date of 7/26/2010" and are net weight 4 ounces in plastic containers...
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