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Food Safety Information for Hurricanes, Power Outages, and Floods

Food and cosmetic announcements - Tue, 2008-09-02 20:00
Food Safety information during and after hurricanes, floods, and power outages; includes information for food industry and retailers.
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Preventing Medical Errors: Mixups between Insulin U-100 and U-500 (April 2008)

Patient safety news - Mon, 2008-09-01 04:00
This story originally aired in April 2008. In this special edition of FDA PSN, we are repeating some of the most important safety issues that continue to pose a public health concern. The Institute for Safe Medication Practices (ISMP) recently des...
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Recalls and Safety Alerts: Severe Pain with Osteoporosis Drugs (March 2008)

Patient safety news - Mon, 2008-09-01 04:00
This story originally aired in March 2008. In this special edition of FDA PSN, we are repeating some of the most important safety issues that continue to pose a public health concern. FDA is alerting healthcare professionals that severe bone, join...
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Recalls and Safety Alerts: Preventing Meningitis in Children with Cochlear Implants (December 2007)

Patient safety news - Mon, 2008-09-01 04:00
This story originally aired in December 2007. In this special edition of FDA PSN, we are repeating some of the most important safety issues that continue to pose a public health concern. FDA is reminding healthcare practitioners about the importan...
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Preventing Medical Errors: More Patient Deaths from Luer Misconnections (October 2007)

Patient safety news - Mon, 2008-09-01 04:00
This story originally aired in October 2007. In this special edition of FDA PSN, we are repeating some of the most important safety issues that continue to pose a public health concern. A recent FDA article in the publication "Safe Practices in Pa...
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Preventing Medical Errors: Preventing Patient Deaths from Fentanyl Patches (September 2007)

Patient safety news - Mon, 2008-09-01 04:00
This story originally aired in September 2007. In this special edition of FDA PSN, we are repeating some of the most important safety issues that continue to pose a public health concern. A recent report from the Institute for Safe Medication Prac...
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Preventing Medical Errors: What to Do about Unretrieved Device Fragments (January 2008)

Patient safety news - Mon, 2008-09-01 04:00
This story originally aired in January 2008. In this special edition of FDA PSN, we are repeating some of the most important safety issues that continue to pose a public health concern. A recent FDA article in the journal Nursing2007 alerts health...
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Salmonella Saintpaul Outbreak - Update

Food and cosmetic announcements - Thu, 2008-08-28 19:53
The FDA has lifted its advice to consumers to avoid eating jalapeno and Serrano peppers grown, harvested or packed in Mexico.
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Class I Medical Device Recall: Pacific Consolidated Industries LLC, Mobile Oxygen Storage Tank

CDRH Comsumer news - Thu, 2008-08-28 04:00
Reason for Recall: The mobile oxygen storage tank?s pressure gauge may rupture and the device may catch fire as a result of hydraulic fluid present in the pressure gauge tubing.
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Survey Data on Lead in Women's and Children's Vitamins

Food and cosmetic announcements - Wed, 2008-08-27 19:32
In early 2007, FDA became aware of reports of elevated lead levels in certain vitamins, which became an issue of concern to FDA, Congress, and the public. This survey was conducted to determine the content of lead (Pb) in vitamins labeled for women and children.
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Web-Based Training Module, "ALERT: Food Defense Awareness" Now Available in Spanish

Food and cosmetic announcements - Fri, 2008-08-22 16:57
FDA is now offering a Spanish version of its web-based training module, "ALERT: Food Defense Awareness".
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FDA Announces Final Rule Amending the Food Additive Regulations to Allow for the Irradiation of Fresh Iceberg Lettuce and Fresh Spinach

Food and cosmetic announcements - Thu, 2008-08-21 22:43
The FDA announced a final rule today amending the food additive regulations to provide for the safe use of ionizing radiation for the control of foodborne pathogens and extension of shelf-life in fresh iceberg lettuce and fresh spinach. FDA has determined that this use will not adversely affect the safety of the food.
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Consumer Information on: T-SPOT.TB - P070006

CDRH Comsumer news - Wed, 2008-08-20 04:00
T-Spot.TB is a laboratory test kit which contains reagents to detect the immune response of Thymus cells (T cells) found in an individual?s white blood cells that are stimulated by proteins produced by the bacteria that causes tuberculosis (TB).
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FDA Warns Consumers Not to Eat Certain Mussel Products from Bantry Bay Seafood

Food and cosmetic announcements - Sat, 2008-08-16 02:54
The FDA is Warning consumers against eating certain frozen cooked mussel products made by Bantry Bay Seafoods, imported from Ireland, because they may be contaminated with azaspiracid toxins, a group of naturally occurring marine toxins known to cause nausea, vomiting, diarrhea, and stomach cramps.
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Federal Register, Final Rule - Food Labeling: Health Claims; Soluble Fiber From Certain Foods and Risk of Coronary Heart Disease

Food and cosmetic announcements - Fri, 2008-08-15 20:31
The FDA is adopting as a final rule, without change, the provisions of the interim final rule (IFR) that amended the regulation authorizing a health claim on soluble fiber from certain foods and risk of coronary heart disease, to add barley betafiber as an additional eligible source of beta-glucan soluble fiber.
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Class I Medical Device Recall: Boston Scientific NexStent Monorail, NexStent Carotid Stent and Monorail Delivery System

CDRH Comsumer news - Thu, 2008-08-14 04:00
The tip of the stent delivery system may detach from the delivery system during the procedure. This could lead to increased procedure time, cause vessel wall injury, stroke and/or emergency surgery to remove the detached tip. Recall does not affect...
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FDA Announces Public Hearing on Food Advisory Labeling

Food and cosmetic announcements - Fri, 2008-08-08 17:53
FDA has scheduled a public hearing on allergen advisory labeling on September 16, 2008. Formal notice of the Hearing published in the Federal Register on August 8, 2008.
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FDA Advice to Retail and Foodservice Operations on Raw Oysters Shipped with "For Cooking Only" Label as Part of a Vibrio parahaemolyticus Control Plan

Food and cosmetic announcements - Wed, 2008-08-06 12:00
FDA is advising retail and foodservice operations to be aware that raw oysters shipped in containers bearing a "For Cooking Only" label may have a greater ikelihood of containing harmful levels of the Vibrio parahaemolyticus (Vp) bacterium, which may cause illness, than do raw oysters not labeled in this manner.
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A Message for Retailers and Food Service Establishments on the Handling, Removal, and and Disposal of Mexican-grown Jalapeno and Serrano Peppers due to Salmonella Saintpaul Hazard

Food and cosmetic announcements - Fri, 2008-08-01 18:46
FDA is currently asking retailers and food service operators to respond immediately to remove and secure for disposal fresh (raw) jalapeno and serrano peppers grown, harvested or packed in Mexico, making sure that all such peppers are not inadvertently made available for use, purchase, salvage or donation and therefore preventing any possibility for human or animal consumption.
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Ginseng Dietary Supplements Special Survey (CFSAN Assignments and Field Regulatory Monitoring for FY 2003 and FY 2004)

Food and cosmetic announcements - Fri, 2008-08-01 18:42
Special survey on pesticide residues found in domestic and imported ginseng dietary supplement products.
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