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: Thu, 29 May 2008 05:07:51 -0500 (CDT)
Subject: CDRH New Update

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

Date: May 29, 2008

The following new items were added to the CDRH web pages on May 28, 2008. Previous CDRH New Items can be found on the CDRHNew Page.

Federal Register: Potential for a Registry of Breast Cancer Treatment Using Thermal Ablation Devices; Request for Comments.

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Message: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 29 May 2008 12:04:53 -0500 (CDT)
Subject: Orval Kent Foods Recalls Single Limited Production Run of Amish Macaroni Salad Sold Under the Orval Kent and Yoder's Brand Names (May 28)

Orval Kent Foods Recalls Single Limited Production Run of Amish Macaroni Salad Sold Under the Orval Kent and Yoder's Brand Names (May 28)
Thu, 29 May 2008 12:02:00 -0500

Orval Kent Foods is voluntarily recalling approximately 23,000 pounds of Amish Macaroni Salad that may pose a health risk. This voluntary action is being taken in response to the results of a test conducted on a single package of Amish Macaroni Salad by the Ohio Department of Agriculture and Consumer Services, Division of Food Safety, for E. coli O157:H7.

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Message: 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 29 May 2008 15:05:09 -0500 (CDT)
Subject: Supreme Cuts Announces Voluntary Recall of Small Sample of Off The Cob Fresh Kernel Corn (May 27)

Supreme Cuts Announces Voluntary Recall of Small Sample of Off The Cob Fresh Kernel Corn (May 27)
Thu, 29 May 2008 14:53:00 -0500

As a precautionary measure, Supreme Cuts LLC has announced that it is voluntarily recalling 87 cases of Off the Cob Fresh Kernel Corn in 12 oz bags. The product may be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail and elderly people, and others with weakened immune systems.

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Message: 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 29 May 2008 15:05:35 -0500 (CDT)
Subject: International Pharmaceuticals, Ltd. Issues a Voluntary Recall of all Viril-Ity-Power (VIP) Tabs, a Product Marketed as a Dietary Supplement (May 29)

International Pharmaceuticals, Ltd. Issues a Voluntary Recall of all Viril-Ity-Power (VIP) Tabs, a Product Marketed as a Dietary Supplement (May 29)
Thu, 29 May 2008 14:38:00 -0500

International Pharmaceuticals, Ltd., announced that it is conducting a voluntary recall of all the company’s supplement product sold under the brand name of Viril-Ity-Power (VIP) Tabs, 560mg/serving.

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Message: 5
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 29 May 2008 09:25:32 -0500 (CDT)
Subject: FDA MedWatch- Mommy's Bliss Nipple Cream: Product Contains Potentially Harmful Ingredients That May Cause Respiratory Distress Or Vomiting And Diarrhea In Infants

FDA informed consumers not to use or purchase Mommy's Bliss Nipple Cream, marketed by MOM Enterprises, Inc., because the product contains potentially harmful ingredients that may cause respiratory distress or vomiting and diarrhea in infants. The product is promoted to nursing mothers to help soothe and heal dry or cracked nipples. Potentially harmful ingredients in the product are chlorphenesin and phenoxyethanol. Chlorphenesin relaxes skeletal muscle and can depress the central nervous system and cause slow or shallow breathing in infants. Phenoxyenthanol, a preservative that is primarily used in cosmetics and medications, can also depress the central nervous system and may cause vomiting and diarrhea, which can lead to dehydration in infants. Mothers and caregivers should seek immediate medical attention if their child shows signs and symptoms of a decrease in appetite, difficulty in awakening, limpness of extremities or a decrease in an infant's strength of grip and a change in skin color.

Read the entire 2008 MedWatch Safety Summary, including a link to the FDA News Release regarding this issue at:

http://www.fda.gov/medwatch/safety/2008/safety08.htm#Bliss

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