Saturday, August 16, 2008

U.S. Food & Drug Administration (FDA) Daily Digest Bulletin

Update: 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 15 Aug 2008 06:02:18 -0500 (CDT)
Subject: S and M (USA) Enterprise Corp. Issues Alert on Undeclared Sulfites in Grove Grow Notes Brand Dried Bamboo Fungus Veiled Lady (August 12)

S and M (USA) Enterprise Corp. Issues Alert on Undeclared Sulfites in Grove Grow Notes Brand Dried Bamboo Fungus Veiled Lady (August 12)
Fri, 15 Aug 2008 06:02:00 -0500

The recall was initiated after routine sampling by New York State Department of Agriculture and Markets food inspectors and subsequent analysis by Food Laboratory personnel revealed the presence of sulfites in Grove Grow Notes brand Dried Bamboo Fungus Veiled Lady which were not declared on the label. The consumption of 10 milligrams of sulfites per serving has been reported to elicit severe reaction in some asthmatics. Anaphylactic shock could occur in certain sulfite sensitive individuals upon ingesting 10 milligrams or more of sulfites


Update: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 15 Aug 2008 07:58:23 -0500 (CDT)
Subject: CDRH New Update

Skip NavigationFDA Logo links to FDA home pageCenter for Devices and Radiological Health, U.S. Food and Drug AdministrationHHS Logo links to Department of Health and Human Services website

FDA Home Page | CDRH Home Page | Search | A-Z Index U.S. Food and Drug AdministrationCenter for Devices and Radiological Health Questions?
horizonal rule
CDRHNEW Logo Date: August 15, 2008

The following new items were added to the CDRH web pages on August 14, 2008. Previous CDRH New Items can be found on the CDRHNew Page.

* Class I Medical Device Recall: Boston Scientific NexStent Monorail, NexStent Carotid Stent and Monorail Delivery System Text
* FDA Workshop: Best Practices For Pacemaker and ICD Lead Postmarket Surveillance, October 2-3, 2008 Text
* Guidance for Industry - Medical Device Tracking; Guidance for Industry and FDA Staff Text PDF
* Federal Register: Medical Devices; Radiology Devices; Reclassification of Bone Sonometers; Correction Text PDF

---


Update: 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 15 Aug 2008 09:02:59 -0500 (CDT)
Subject: Mars Petcare US Issues Voluntary Recall of Limited Bags of PEDIGREE Complete Nutrition Small Crunchy Bites at Albertsons in Southern California and Las Vegas due to Potential Salmonella Contamination (August 8)

Mars Petcare US Issues Voluntary Recall of Limited Bags of PEDIGREE Complete Nutrition Small Crunchy Bites at Albertsons in Southern California and Las Vegas due to Potential Salmonella Contamination (August 8)
Fri, 15 Aug 2008 08:35:00 -0500

Mars Petcare US today announced a voluntary recall of limited bags of PEDIGREE® Complete Nutrition Small Crunchy Bites sold in Albertsons stores in Southern California and Las Vegas, Nevada. The pet food is being voluntarily recalled because of potential contamination with Salmonella. There have been no complaints or reports of injury resulting from consumption or handling of the recalled product.


Update: 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 15 Aug 2008 09:04:29 -0500 (CDT)
Subject: Whole Foods Market Issues Recall on 365 Organic Everyday Value Popcorn, Lightly Salted Due to Undeclared Dairy Allergen (August 14)

Whole Foods Market Issues Recall on 365 Organic Everyday Value Popcorn, Lightly Salted Due to Undeclared Dairy Allergen (August 14)
Fri, 15 Aug 2008 08:35:00 -0500

This product was distributed to and sold in Whole Foods Market retail stores in California, Arizona, Nevada, Kentucky, Maryland, Ohio, Pennsylvania, Virginia, Washington D.C, Connecticut, Maine, Massachusetts, Rhode Island, Oregon, New Jersey, New York and Washington.


Update: 5
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 15 Aug 2008 14:02:34 -0500 (CDT)
Subject: FDA Approves First Drug for Treatment of Chorea in Huntington's Disease

FDA Approves First Drug for Treatment of Chorea in Huntington's Disease
Fri, 15 Aug 2008 13:23:00 -0500

The U.S. Food and Drug Administration has approved Xenazine (tetrabenazine) for the treatment of chorea in people with Huntington's disease. Chorea is the jerky, involuntary movement that occurs in people with this disease.


Update: 6
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 15 Aug 2008 16:03:49 -0500 (CDT)
Subject: Peppers Unlimited, Inc. Recalls La Torre Jalapeno Nacho Slices (August 14)

Peppers Unlimited, Inc. Recalls La Torre Jalapeno Nacho Slices (August 14)
Fri, 15 Aug 2008 15:35:00 -0500

Peppers Unlimited, Inc. of Fontana California is voluntarily recalling 580 cases of La Torre Jalapeno Nacho Slices because of possible product contamination caused by a chemical reaction between the product and the can potentially resulting in a swollen and/or ruptured container and significant off flavor.


Update: 7
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 15 Aug 2008 21:03:12 -0500 (CDT)
Subject: FDA Warns Consumers Not to Eat Certain Mussel Products from Bantry Bay Seafood (August 15)

FDA Warns Consumers Not to Eat Certain Mussel Products from Bantry Bay Seafood (August 15)
Fri, 15 Aug 2008 18:30:00 -0500

The U.S. Food and Drug Administration (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.


This service is provided to you at no charge by U.S. Food & Drug Administration (FDA).

GovDelivery, Inc. sending on behalf of U.S. Food & Drug Administration (FDA) · 5600 Fishers Lane · Rockville MD 20857 · 800-439-1420