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, 27 May 2008 05:41:17 -0500 (CDT)
Subject: CDRH New Update

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

Date: May 27, 2008

The following new items were added to the CDRH web pages on May 23, 2008. Previous CDRH New Items can be found on the CDRHNew Page.

	Guidance for Industry - Medical Device Tracking; Guidance for Industry and FDA Staff
	HHS News: New Efforts to Help Improve Medical Products for Patient Safety and Quality of Medical Care

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Message: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 27 May 2008 17:35:04 -0500 (CDT)
Subject: FDA Requests Recall of Xiadafil VIP Tabs

FDA Requests Recall of Xiadafil VIP Tabs
Tue, 27 May 2008 14:08:00 -0500

The U.S. Food and Drug Administration today requested that SEI Pharmaceuticals, of Miami, Fla., recall all Xiadafil VIP Tabs sold in 8 tablet bottles (Lot # 6K029) or blister cards of 2 tablets (Lot # 6K029-SEI) because these products contain a potentially harmful, undeclared ingredient that may dangerously affect a person's blood pressure and can cause other life-threatening side effects.

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Message: 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 27 May 2008 16:45:05 -0500 (CDT)
Subject: FDA MedWatch- Xiadafil VIP Tablets- Product Contains Potentially Harmful, Undeclared Ingredient That May Cause Life-Threatening Side Effects

FDA alerted consumers and healthcare professionals not to buy or use Xiadafil VIP Tablets sold in bottles of 8 tablets (Lot #6K029) or blister cards of 2 tablets (Lot# 6K029-SEI). The product is marketed as a dietary supplement and is promoted and sold over the internet for sexual enhancement and to treat erectile dysfunction (ED). The product contains a potentially harmful, undeclared ingredient that may dangerously affect a person's blood pressure and can cause other life-threatening side effects. Xiadafil VIP Tablets contain hydroxyhomosildenafil, an analog of sildenafil, the active ingredient in Viagra, an FDA approved prescription drug for ED. The undeclared ingredient may interact with nitrates found in some prescription drugs and can lower blood pressure to life-threatening levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Consumers who have used the product should discontinue use immediately and consult their healthcare professional if they have experienced any adverse events that they believe may be related to the use of this product.

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

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

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

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

You have requested to receive a Daily Digest e-mail from U.S. Food & Drug Administration (FDA).

Message: 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 23 May 2008 08:03:38 -0500 (CDT)
Subject: CDRH New Update

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

Date: May 23, 2008

The following new items were added to the CDRH web pages on May 22, 2008. Previous CDRH New Items can be found on the CDRHNew Page.

	Federal Register: Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting.
	Federal Register: Ophthalmic Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting.

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Message: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 23 May 2008 19:04:04 -0500 (CDT)
Subject: FDA Warns Consumers Against Using Mommy's Bliss Nipple Cream

FDA Warns Consumers Against Using Mommy's Bliss Nipple Cream
Fri, 23 May 2008 18:32:00 -0500

The U.S. Food and Drug Administration is warning 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.

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

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

You have requested to receive a Daily Digest e-mail from U.S. Food & Drug Administration (FDA).

Message: 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 22 May 2008 13:05:12 -0500 (CDT)
Subject: New Efforts to Help Improve Medical Products for Patient Safety and Quality of Medical Care

New Efforts to Help Improve Medical Products for Patient Safety and Quality of Medical Care
Thu, 22 May 2008 12:15:00 -0500

HHS Secretary Mike Leavitt today announced efforts underway at the U.S. Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) that will complement each other to improve patient safety and the quality of medical care.

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

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

You have requested to receive a Daily Digest e-mail from U.S. Food & Drug Administration (FDA).

Message: 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 21 May 2008 07:51:44 -0500 (CDT)
Subject: CDRH New Update

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

Date: May 21, 2008

The following new items were added to the CDRH web pages on May 20, 2008. Previous CDRH New Items can be found on the CDRHNew Page.

	FDA Workshop: Exploration of Public Policy Development Regarding the Study and Analysis of Sex Differences in the Clinical Evaluation of Cardiovascular Medical Products, June 2, 2008
	Federal Register: Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Plasmodium Species Antigen Detection Assays; Availability.
	Federal Register: Medical Devices; Immunology and Microbiology Devices; Classification of Plasmodium Species Antigen Detection Assays.

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Message: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 21 May 2008 08:36:39 -0500 (CDT)
Subject: FDA Warning Letters Update

You are subscribed to FDA Warning Letters for U.S. Food & Drug Administration (FDA). This information has recently been updated, and is now available.

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