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: Mon, 14 Apr 2008 06:17:14 -0500 (CDT)
Subject: CDRH New Update

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

Date: April 14, 2008

The following new items were added to the CDRH web pages on April 11, 2008. Previous CDRH New Items can be found on the CDRHNew Page.

Consumer Information on: CONTAK RENEWAL® 3 AVT® Models M150, M155, M157 and M159 - P010012S037

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Message: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 14 Apr 2008 11:07:46 -0500 (CDT)
Subject: Private Selection Ice Cream Recalled From Kroger Stores In Twelve Southeastern States (April 7)

Private Selection Ice Cream Recalled From Kroger Stores In Twelve Southeastern States (April 7)
Mon, 14 Apr 2008 10:50:00 -0500

Inter-American Products, Inc., a division of The Kroger Co., today announced a recall on two codes of Private Selection Light Churned Mint Chocolate Chip Ice Cream in 1.75-quart containers with a "Sell By" date of December 3, 2008. The two codes are: DEC0308 8070 and DEC0308 8080.

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Message: 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 14 Apr 2008 13:03:28 -0500 (CDT)
Subject: FDA MedWatch- Herbal Science International, Inc. Recalls Dietary Herbal Supplements Because They May Present A Serious Health Hazard To Consumers

Herbal Science International, Inc. and FDA informed consumers and healthcare professionals of a nationwide recall of twelve dietary supplements that contain ephedra, aristolochic acid or human placenta because they may present a serious health hazard to consumers. FDA has long regarded dietary supplements containing ephedra, a botanical that contains ephedrine alkaloids, as a potential health hazards because the alkaloid raises blood pressure and otherwise stress the circulatory system. These effects are linked to adverse health effects like heart attacks and stroke. FDA issued a rule in February 2004 prohibiting the sale of dietary supplements containing ephedrine alkaloids because they present an unreasonable risk of illness or injury.

Two of the recalled products contain aristolochic acid which is a potent carcinogen and nephrotoxin. This chemical can cause serious kidney damage and has been associated with several occurrences of kidney failure. The twelfth recalled product contains human placenta, an ingredient which may transmit disease. Dietary supplements that contain human placenta may not be lawfully marketed in the United States. No illnesses have been reported in connection with the recalled products and distribution of all of the products has ceased. Consumers should immediately discontinue use of the recalled products and return the product(s) to their place of purchase.

Read the entire 2008 MedWatch Safety Summary, including a link to the manufacturer's press release regarding this issue and a list of the recalled products at:   http://www.fda.gov/medwatch/safety/2008/safety08.htm#Herbal

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