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, 16 May 2008 06:08:24 -0500 (CDT)
Subject: CDRH New Update

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

Date: May 16, 2008

The following new items were added to the CDRH web pages on May 15, 2008. Previous CDRH New Items can be found on the CDRHNew Page.

Inspection of Domestic and Foreign Manufacturers of Diagnostic X Ray Equipment

---

Message: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 16 May 2008 09:05:16 -0500 (CDT)
Subject: FDA Shuts Down Seafood Processing Company, Requires Products Be Recalled

FDA Shuts Down Seafood Processing Company, Requires Products Be Recalled
Fri, 16 May 2008 08:31:00 -0500

The U.S. Food and Drug Administration today directed Hope Food Supply Inc., a Pasadena, Texas, food processing company, to shut down and immediately recall all products manufactured from its Texas facility since 2007.

---

Message: 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 16 May 2008 09:05:21 -0500 (CDT)
Subject: FDA Shuts Down Seafood Processing Company, Requires Products Be Recalled (May 16)

FDA Shuts Down Seafood Processing Company, Requires Products Be Recalled (May 16)
Fri, 16 May 2008 08:44:00 -0500

The U.S. Food and Drug Administration directed Hope Food Supply Inc., a Pasadena, Texas, food processing company, to shut down and immediately recall all products manufactured from its Texas facility since 2007.

---

Message: 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 16 May 2008 09:05:49 -0500 (CDT)
Subject: FDA Obtains Permanent Injunction Against Scientific Laboratories, Inc.

FDA Obtains Permanent Injunction Against Scientific Laboratories, Inc.
Fri, 16 May 2008 08:31:00 -0500

The U.S. Food and Drug Administration (FDA) today announced that Scientific Laboratories Inc., and its president, Rajeshwari Patel, and chief executive officer, Amit Roy, have signed a Consent Decree of Permanent Injunction and are barred from manufacturing and distributing drug products until they bring their manufacturing operations into compliance with law and obtain approval for their products.

---

Message: 5
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 16 May 2008 14:12:01 -0500 (CDT)
Subject: FDA MedWatch - FDA Alert and Healthcare Professional Information Sheet issued for Mycophenolate Mofetil (CellCept) and Mycophenolic Acid (Myfortic)

FDA is aware of reports of infants born with serious congenital anomalies, including microtia and cleft lip and palate, following exposure to mycophenolate mofetil (MMF) during pregnancy. MMF, the active drug substance in CellCept, is an ester of the active metabolite mycophenolic acid (MPA), the active drug substance in Myfortic. In most cases, the mothers were taking MMF following an organ transplant to prevent organ rejection. However, some mothers taking MMF were being treated for immune-mediated conditions such as systemic lupus erythematosus (SLE) and erythema multiforme. Treatment began before their pregnancies and continued into the first trimester or until the pregnancy was detected. MMF and MPA increase the risk of spontaneous abortion in the first trimester and can cause congenital malformations in the offspring of women who are treated during pregnancy.

FDA is continuing to work with the manufacturers of these drug products to develop and implement means to mitigate the risks of fetal exposure. See the FDA Healthcare Professional Information Sheet containing considerations and recommendations for clinicians prior to prescribing MMF or MPA to women of childbearing potential.

Read the entire 2008 MedWatch Safety Summary, including a link to the FDA Alert and Healthcare Professional Information Sheet regarding this issue at:

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

---

Update your subscriptions, modify your e-mail address, or stop subscriptions at any time on your Subscriber Preferences Page. You will need to use your e-mail address to log in. If you have questions or problems with the subscription service, please contact support@govdelivery.com.

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