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

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Message: 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 26 Feb 2008 05:41:08 -0600 (CST)
Subject: CDRH New Update

	FDA Home Page | CDRH Home Page | Search | A-Z Index

Date: February 26, 2008

The following new items were added to the CDRH web pages on February 25, 2008. Previous CDRH New Items can be found on the CDRHNew Page.

	Advice for Patients: Denture Cleansers
	FDA Public Health Notification: Denture Cleanser Allergic Reactions and Misuse
	Questions and Answers on Chattem, Inc. Icy Hot Heat Therapy Air Activated Heat (Back and Arm, Neck & Leg)

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Message: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 26 Feb 2008 12:06:02 -0600 (CST)
Subject: Wang Globalnet Issues Allergy Alert on Undeclared Eggs, Peanuts and Milk Allergens in Lotte Margaret Brand Korean Cracker (Feb. 14)

Wang Globalnet Issues Allergy Alert on Undeclared Eggs, Peanuts and Milk Allergens in Lotte Margaret Brand Korean Cracker (Feb. 14)
Tue, 26 Feb 2008 10:31:00 -0600

Wang Globalnet is recalling 19 gram packages of Lotte Margaret Brand Korean Cracker because they may contain undeclared eggs, peanuts and milk allergens. Consumers who are allergic to eggs, peanuts and milk may run the risk of serious or life-threatening allergic reactions if they consume this product. The product comes in a 19 gram cardboard box marked with item#: 00438 on the top and a code date of 08.08.06.B2 stamped on the side. The recalled packages of Lotte Margaret Brand Korean Cracker were distributed nationwide in retail stores.

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Message: 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 26 Feb 2008 14:06:38 -0600 (CST)
Subject: Summit Import Corporation Issues an Alert on Uneviscerated Fish (Feb. 12)

Summit Import Corporation Issues an Alert on Uneviscerated Fish (Feb. 12)
Tue, 26 Feb 2008 12:48:00 -0600

Summit Import Corp. is recalling all packages of Sum Cheong Lung brand Dried Fish discovered by New York State Dept. of Agriculture and Markets Food Inspectors during a routine inspection and subsequent analysis of the product by Food Laboratory personnel confirming that the fish had not been eviscerated prior to processing. This product may be contaminated with Clostridium botulinum spores, which can cause Botulism, a serious and potentially fatal foodborne illness.

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Message: 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 26 Feb 2008 11:03:17 -0600 (CST)
Subject: FDA MedWatch - Avandia (rosiglitazone maleate): new Medication Guide issued

FDA and GlaxoSmithKline notified pharmacists and physicians of a new Medication Guide for Avandia (rosiglitazone maleate). The FDA regulation 21CFR 208 requires a Medication Guide to be provided with each prescription that is dispensed for products that FDA determines pose a serious and significant public health concern. A list of currently approved Medication Guides are available at http://www.fda.gov/cder/Offices/ODS/medication_guides.htm.

See the MedWatch 2008 safety summary, including links to the Medication Guide and the current Prescribing Information for Avandia, at:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#Avandia

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Message: 5
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 26 Feb 2008 11:07:31 -0600 (CST)
Subject: FDA MedWatch - Denture Cleanser Allergic Reactions and Misuse

FDA notified dental healthcare professionals and patients of the risk of serious allergic reactions in users of denture cleansers. These adverse events, including abdominal pain, vomiting, seizures, hypotension and difficulty breathing, have occurred both when the product has been used properly as well as from improper use. These events can occur soon after first use or after years of use. FDA believes that the ingredient responsible for these reactions is persulfate, a known allergen. Persulfates are used in most denture cleansers to help clean and bleach the dentures. FDA has provided specific recommendations for dental healthcare professionals and an 'Advice for Patients' document.

FDA is recommending that all manufacturers of denture cleansers modify their labeling to include warning information that the product contains persulfates and recommends improving the directions for use on their labeling in order to reduce misuse.

See the MedWatch 2008 safety summary, including links to the Public Health Notification and "Advice for Patients", at:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#Denture
 

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