FDA

The Nuthouse, Los Angeles, Conducts Voluntarily Recall of Pistachios Due to Possible Health Risks (May 8)

FDA Recalls - Mon, 2009-05-11 12:43
The repacked pistachios were sold from August 10, 2008 through December 31, 2008, at the Los Angeles Wholesale Produce Market in California either in unlabeled brown plastic lined paper bags or white cardboard boxes with plastic inner liners.
Categories: FDA

FDA Approves Drug for Treatment of Aggressive Brain Cancer

FDA Press - Fri, 2009-05-08 18:57
The U.S. Food and Drug Administration recently approved Avastin (bevacizumab) to treat patients with glioblastoma multiforme (GBM) when this form of brain cancer continues to progress following standard therapy.
Categories: FDA

Iovate Health Sciences U.S.A., Inc. Adds Hydroxycut-Branded Product Universal Product Codes to its Voluntary Nationwide Recall (May 7)

FDA Recalls - Fri, 2009-05-08 14:09
Iovate Health Sciences USA, Inc. of Blasdell, New York and Ontario, Canada announced today that it is adding Universal Product Codes (UPCs) with respect to the Hydroxycut-branded products sold in the United States and subject to the voluntary recall.
Categories: FDA

President's FY 2010 Budget for FDA Invests Substantially in Food and Medical Product Safety

FDA Press - Thu, 2009-05-07 17:47
The U.S. Food and Drug Administration, part of the U.S. Department of Health and Human Services, is requesting a budget of $3.2 billion to protect and promote the public health as part of the President's fiscal year (FY) 2010 budget - a 19 percent increase over the current FDA fiscal year budget.
Categories: FDA

FDA: More than $1.5 Million of Adulterated Food, Food Ingredients Seized

FDA Press - Thu, 2009-05-07 17:19
At the request of the U.S. Food and Drug Administration, U.S. Marshals today seized more than $1.5 million worth of food products, including herbs and botanicals, stored under filthy conditions at the American Mercantile Corporation of Memphis, Tenn.
Categories: FDA

Testosterone Gel Safety Concerns Prompt FDA to Require Label Changes, Medication Guide

FDA Press - Thu, 2009-05-07 16:03
The U.S. Food and Drug Administration today announced that it is requiring manufacturers of two prescription topical testosterone gel products, AndroGel 1 percent and Testim 1 percent, to include a boxed warning on the products' labels. The agency is requiring this action after receiving reports of adverse effects in children who were inadvertently exposed to testosterone through contact with another person being treated with these products (secondary exposure).
Categories: FDA

FDA Approves Pancreatic Enzyme Replacement Product for Marketing in United States

FDA Press - Thu, 2009-05-07 14:40
The U.S. Food and Drug Administration announced today that it has approved Creon (pancrelipase), a pancreatic enzyme replacement product designed to help patients with cystic fibrosis and others with exocrine pancreatic insufficiency (EPI) digest and absorb nutrients from foods. Creon is the first FDA-approved delayed-release pancreatic enzyme replacement product to be marketed in the United States as a result of the agency’s unapproved drugs initiative.
Categories: FDA

FDA Approves Fanapt to Treat Schizophrenia

FDA Press - Wed, 2009-05-06 21:00
The U.S. Food and Drug Administration has approved Fanapt tablets (iloperidone) to treat adults with schizophrenia, a chronic, severe and disabling brain disorder. "Schizophrenia can be a devastating illness requiring lifelong treatment and therapy," said Thomas Laughren, M.D., director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research. "Medications for schizophrenia can ease many symptoms, allowing people to live more independent lives."
Categories: FDA

FDA Approves New Influenza Vaccine Production Facility

FDA Press - Wed, 2009-05-06 20:30
The U.S. Food and Drug Administration (FDA) announced that it has approved a new manufacturing facility used to produce influenza virus vaccines. The facility is approved for seasonal influenza vaccine production and could be used for the production of vaccine against the new 2009 H1N1 influenza strain.
Categories: FDA

Biosite Incorporated Issues Voluntary, Nationwide Recall for Cardiac Marker Test (May 5)

FDA Recalls - Wed, 2009-05-06 17:28
The recall is limited to the Triage Cardiac Panel, Catalog No. 97000HS, Lot No. W44467B. Biosite Incorporated has notified its customers via overnight mail and has instructed them to discontinue use of the affected lot and discard any remaining product from the lot that is on hand. The identified lot was distributed to clinical labs in the United States between January and February 2009. Replacement product will be provided to clinical labs with remaining inventory of this affected product lot.
Categories: FDA

LeClerc Foods Announces a Limited Nationwide Voluntary Recall of Market Pantry Chocolate Chip Chewy Granola Bars due to Unlabeled Peanut Allergen (May 5)

FDA Recalls - Wed, 2009-05-06 15:50
The recall was initiated as a precautionary measure after it was discovered that product was mispackaged and the retail units may also contain Peanut Butter Chocolate Chip Bars and S'more Bars. As a result the ingredient statement on the retail package does not include peanuts as an ingredient. People who have allergies to peanuts run the risk of serious or life threatening allergic reactions if they consume this product.
Categories: FDA

King Henry's Voluntarily Conducts Recall of Pistachios due to Possible Health Risks (May 5)

FDA Recalls - Wed, 2009-05-06 11:27
King Henry's Inc of Valencia, California is voluntarily recalling all Pistachio sold under the King Henry label in 1.5oz, 2.75oz and 4.5oz packages as they have the potential to be contaminated with Salmonella. This voluntary recall is being conducted as a precautionary measure due to the fact that the in-shell pistachios are being recalled by Setton Pistachio of Terra Bella, Inc.
Categories: FDA

AZ Hydroponic Farming Recalls 4oz Alfalfa Sprout Cup Because of Possible Health Risk (May 4)

FDA Recalls - Tue, 2009-05-05 19:57
The product in question was distributed throughout Arizona and to one customer in California. The product comes in a 4 ounce, clear plastic package labeled with either AZ Hydroponic Farming expiration date 4/18/2009 or with LA CALCO expiration date 4/23/2009. The packaging is a 4 x 4 x 4 inch cubed plastic container with a perforated bottom.
Categories: FDA

Recall of Product Containing In-Shell Pistachios Due To Possible Health Risk (April 30)

FDA Recalls - Mon, 2009-05-04 21:44
The Wisconsin Cheeseman of Sun Prairie, WI is conducting a voluntary recall of the product listed below. This voluntary recall is being conducted as a precautionary measure due to the fact that the in-shell pistachios are being recalled by Setton Pistachio of Terra Bella, Inc. because they may be contaminated with Salmonella.
Categories: FDA

Sugar Foods Issues Allergy Alert on Undeclared Milk in The Farmers Market Butter and Garlic Crouton Products (May 1)

FDA Recalls - Mon, 2009-05-04 17:44
The Farmers Market Butter and Garlic croutons were distributed to Giant Eagle stores located in the Northeastern United States.
Categories: FDA

Sheridan Fruit Company Recalls Bulk and Packaged Raw Pistachios Because of Possible Health Risk (May 1)

FDA Recalls - Mon, 2009-05-04 14:30
Sheridan Fruit Company of Portland, Oregon is recalling 12 oz. packages of Sheridan Fruit Company Raw Pistachio Meats, and Bulk Raw Pistachio Kernels sold between February 5th and March 30th, 2009 because they have the potential to be contaminated with Salmonella.
Categories: FDA

Iovate Health Sciences U.S.A., Inc. Voluntarily Recalls Hydroxycut-Branded Products (May 1)

FDA Recalls - Mon, 2009-05-04 11:44
Iovate Health Sciences USA, Inc. of Blasdell, New York and Ontario, Canada announced that it is voluntarily recalling Hydroxycut branded products sold in the United States.
Categories: FDA

FDA, FTC Warn Public of Fraudulent 2009 H1N1 Influenza Products

FDA Press - Fri, 2009-05-01 18:30
The U.S. Food and Drug Administration and the Federal Trade Commission are alerting the public to be wary of Internet sites and other promotions for products that claim to diagnose, prevent, mitigate, treat or cure the 2009 H1N1 influenza virus. The agencies are also advising operators of offending web sites that they must take prompt action to correct and/or remove promotions of these fraudulent products or face enforcement action.
Categories: FDA

FDA Warns Consumers to Stop Using Hydroxycut Products (May 1)

FDA Recalls - Fri, 2009-05-01 15:00
The U.S. Food and Drug Administration is warning consumers to immediately stop using Hydroxycut products by Iovate Health Sciences Inc., of Oakville, Ontario and distributed by Iovate Health Sciences USA Inc. of Blasdell, N.Y. Some Hydroxycut products are associated with a number of serious liver injuries. Iovate has agreed to recall Hydroxycut products from the market.
Categories: FDA

FDA Warns Consumers to Stop Using Hydroxycut Products

FDA Press - Fri, 2009-05-01 15:00
The U.S. Food and Drug Administration is warning consumers to immediately stop using Hydroxycut products by Iovate Health Sciences Inc., of Oakville, Ontario and distributed by Iovate Health Sciences USA Inc. of Blasdell, N.Y. Some Hydroxycut products are associated with a number of serious liver injuries. Iovate has agreed to recall Hydroxycut products from the market.
Categories: FDA
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