Update : 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 5 Sep 2008 06:02:50 -0500 (CDT)
Subject: Starway Inc. Issues Alert on Undeclared Sulfites in Ego Brand Preserved Peaches (September 3)
Starway Inc. Issues Alert on Undeclared Sulfites in Ego Brand Preserved Peaches (September 3)
Fri, 05 Sep 2008 05:44:00 -0500
EGO brand Preserved Peaches is sold in a 14 ounce, un-coded, clear plastic package and was distributed nationwide. It is a product of Malaysia.
Update : 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 5 Sep 2008 08:02:27 -0500 (CDT)
Subject: The Hershey Company Announces Nationwide Voluntary Recall of Hershey's Chocolate Shell Topping Due to Undeclared Almonds (September 4)
The Hershey Company Announces Nationwide Voluntary Recall of Hershey's Chocolate Shell Topping Due to Undeclared Almonds (September 4)
Fri, 05 Sep 2008 07:52:00 -0500
The only 7.25-ounce bottles of Hershey's Chocolate Shell Topping affected have the code 69N printed on the back of the bottle below the UPC symbol. The UPC/Bar Code is 346000. The item in question was available for purchase nationwide after July 8, 2008.
Update : 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 5 Sep 2008 08:09:20 -0500 (CDT)
Subject: CDRH New Update
    |
| FDA Home Page | CDRH Home Page | Search | A-Z Index |  | |
 | ||
 | Date: September 5, 2008 |
The following new items were added to the CDRH web pages on September 4, 2008. Previous CDRH New Items can be found on the CDRHNew Page.
 | Medical Device Safety, Tips & Articles: Cutting a Battery Pack Cable Can Start a Fire |  |
| Orthopaedic and Rehabilitation Devices Panel Advisory Meeting, April 24, 2007 - Minutes | |
Update : 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 5 Sep 2008 11:03:35 -0500 (CDT)
Subject: FDA to Post Quarterly Report of Potential Safety Issues
FDA to Post Quarterly Report of Potential Safety Issues
Fri, 05 Sep 2008 10:57:00 -0500
The U.S. Food and Drug Administration announced today that it has posted on its Web site its first quarterly report that lists certain drugs that are being evaluated for potential safety issues. The drugs have been identified based on a review of reports in FDA's Adverse Event Reporting System (AERS).
Update : 5
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 5 Sep 2008 11:03:53 -0500 (CDT)
Subject: Drug Information Update- FDA to Post Quarterly Report of Potential Safety Issues
The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.
The U.S. Food and Drug Administration announced today that it has posted on its Web site its first quarterly report that lists certain drugs that are being evaluated for potential safety issues. The drugs have been identified based on a review of reports in FDA's Adverse Event Reporting System (AERS).
The information is being provided under provisions of the Food and Drug Administration Amendments Act, signed into law Sept. 27, 2007. The law requires that FDA inform the public each quarter of new safety information or potential signals of serious risk, based on the agency's review of adverse event reports contained in AERS.
The appearance of a drug on this list does not mean that FDA has concluded that the drug has the listed risk, or that FDA has identified a causal relationship between the drug and the listed risk. It is on the list only because FDA has identified a potential safety issue.
"My message to patients is this: Don't stop taking your medicine. If your doctor has prescribed a drug that appears on this list, you should continue taking it unless your doctor advises you differently," said Janet Woodcock, M.D., director of FDA's Center for Drug Evaluation and Research.
Drugs that appear on the agency's new AERS-based table, titled "Potential Signals of Serious Risks/New Safety Information," are identified by FDA reviewers based on reports from the FDA's AERS database, which contains millions of reports of adverse events submitted to FDA by drug manufacturers, health care professionals and patients. For a drug to appear on this report, an FDA reviewer will have determined there is a reason to examine a drug more closely based on either the seriousness or number of AERS reports associated with the drug. The drugs for which issues have been identified are under evaluation for the listed potential risk.
This first quarterly report, posted to FDA's Web site today, lists 20 drugs along with the potential safety issue associated with each drug. Each quarter, a new report will be posted to FDA's Web site listing additional drugs for which new safety information or potential signals of serious risks have been identified through AERS. The quarterly reports will not be cumulative; they will list only drugs for which new safety information or potential signals of serious risks have been identified through AERS during the previous quarter.
A new quarterly report listing additional drugs for which new safety information or potential signals of serious risks have been identified through AERS will be posted to the FDA's Web site every three months.
"Over the past two years, FDA has become much more proactive in our communication about possible safety problems," Woodcock said. "Patients and health care professionals have told us that they want to be informed about possible safety problems sooner. They want to know when FDA is in the early stages of looking into a potential safety problem. Congress took note of this when it directed us to post this quarterly report of potential safety issues."
For more information, please visit:
http://www.fda.gov/cder/aers/potential_signals/default.htm
http://www.fda.gov/cder/aers/potential_signals/potential_signals_2008Q1.htm
Update : 6
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 5 Sep 2008 14:02:39 -0500 (CDT)
Subject: T. Marzetti Company Recalls a Limited Number of Girard's Honey Dijon Peppercorn (September 4)
T. Marzetti Company Recalls a Limited Number of Girard's Honey Dijon Peppercorn (September 4)
Fri, 05 Sep 2008 13:33:00 -0500
T. Marzetti Company is recalling a limited number of 12 fl. oz. bottles of Girard's Honey Dijon Peppercorn (item 58105) because they may have the incorrect back label of Girard's French Dressing (item 58015). The Girard's Honey Dijon Peppercorn contains eggs, which is not declared as an ingredient on the Girard's French label. People who have allergies to egg run the risk of serious allergic reaction if they consume this product.
Update : 7
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 5 Sep 2008 14:04:09 -0500 (CDT)
Subject: Sprouters Northwest, Inc. Recalls Alfalfa Sprout Products Because of Possible Health Concern (September 5)
Sprouters Northwest, Inc. Recalls Alfalfa Sprout Products Because of Possible Health Concern (September 5)
Fri, 05 Sep 2008 13:58:00 -0500
Sprouters Northwest, Inc. of Kent, Washington is recalling its alfalfa sprout products (alfalfa sprouts, onion sprouts, and salad sprouts) because they may be linked to a recent outbreak of Salmonellosis in Oregon and Washington State. To date, 13 cases of Salmonella Typhimirium infection have been associated with the consumption of raw alfalfa sprouts.
Update : 8
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 5 Sep 2008 14:05:45 -0500 (CDT)
Subject: What's New at CBER Update
You are subscribed to What's New at CBER for U.S. Food & Drug Administration (FDA). This information has recently been updated, and is now available.
Medical Device Notification (PSN-08-06) - Sunquest Laboratory Blood Bank and Blood Donor Modules - Sunquest Information Systems, Inc.
Posted: 9/5/2008, Recall Date: 8/15/2008
Message: 9
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 5 Sep 2008 14:13:56 -0500 (CDT)
Subject: U.S. Food & Drug Administration (FDA) CBER's Recalls, Withdrawals, Field Corrections & Notifications Update
You are subscribed to CBER's Recalls, Withdrawals, Field Corrections & Notifications for U.S. Food & Drug Administration (FDA). This information has recently been updated, and is now available.
Update : 10
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 5 Sep 2008 14:51:16 -0500 (CDT)
Subject: What's New at CBER Update
You are subscribed to What's New at CBER for U.S. Food & Drug Administration (FDA). This information has recently been updated, and is now available.
Licensed Products and Establishments List - Update
Posted: 9/5/2008, Updated through: 8/31/2008
Cleared Biological 510(k) Device Applications - Update
Posted: 9/5/2008, Updated through: 8/31/2008
Approved Biological Premarket Approval (PMA) Device Applications - Update
Posted: 9/5/2008, Updated through: 8/31/2008
Approved Biological NDA and ANDA Applications - Update
Posted: 9/5/2008, Updated through: 8/31/2008
Update : 11
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 5 Sep 2008 17:03:13 -0500 (CDT)
Subject: Recall of Patak's Dopiaza Cooking Sauce (September 4)
Recall of Patak's Dopiaza Cooking Sauce (September 4)
Fri, 05 Sep 2008 17:00:00 -0500
ACH Food Companies, Inc. is recalling its Patak's Dopiaza Cooking Sauce sold in the United States because it may contain an undeclared milk allergen. People who have an allergy or severe sensitivity to milk may run the risk of serious or life-threatening allergic reaction if they consume these products. The product is distributed nationally through retail stores. ACH Food Companies is notifying its distributors and stores that carry this product that it contains an undeclared milk allergen and to immediately remove it from distribution.
Update : 12
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 5 Sep 2008 19:04:12 -0500 (CDT)
Subject: The FDA this Week: Andy's Take -- FDA: Working for You
The FDA this Week: Andy's Take -- FDA: Working for You
Fri, 05 Sep 2008 21:00:00 -0500
Remember stories of the problems with melamine contaminating your pet's food? Illegal substances in heparin causing serious reactions in patients? And most recently, bacteria in food causing thousands of people across the country to get sick? How can FDA keep up with all these challenges and deal with all the issues?
My Take is that to do more to protect and promote your health, FDA needs more people.
This service is provided to you at no charge by U.S. Food & Drug Administration (FDA).
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