Tuesday, July 22, 2008

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

Update: 1

From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 21 Jul 2008 09:02:51 -0500 (CDT)
Subject: Grande Produce, LTD.CO Recalls Jalapeno Peppers, Serrano Peppers, and Avocados Because of Possible Health Risk (July 19)

Grande Produce, LTD.CO Recalls Jalapeno Peppers, Serrano Peppers, and Avocados Because of Possible Health Risk (July 19)
Mon, 21 Jul 2008 09:00:00 -0500

The Jalapeno Peppers, Serrano Peppers and Avocados were distributed to the following states: TX, DE, NC, GA, OK, IA, MN, IL, FL, IN, MD, NY, MS, AR, KS, and KY. The avocados being recalled were shipped in boxes labeled "Frutas Finas de Tancitaro HASS Avocados, Produce of Mexico," all sizes, with lot number HUE08160090889. The Jalapeno Peppers and Serrano peppers being recalled were shipped in 35lb. plastic crates with no brand name or label.


Update: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 21 Jul 2008 14:04:41 -0500 (CDT)
Subject: Domega International Co., Ltd. Issues an Alert on Undeclared Sulfites in Korica Brand Mut Gung Sweetened Ginger (July 16)

Domega International Co., Ltd. Issues an Alert on Undeclared Sulfites in Korica Brand Mut Gung Sweetened Ginger (July 16)
Mon, 21 Jul 2008 13:38:00 -0500

The recalled Korica Brand Mut Gung Sweetened Ginger is sold in uncoded 7 oz plastic tubs and is a product of Vietnam. The product was sold nationwide.


Update: 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 21 Jul 2008 15:47:22 -0500 (CDT)
Subject: CDER New 7/16 18/2008

FDA Logo links to FDA home page
Center for Drug Evaluation and Research, U.S. Food and Drug Administration
HHS Logo links to Department of Health and Human Services website

CDERnew Logo

July 17, 2008

  • FDA updates healthcare professionals about recent changes made to the Boxed Warning, Warnings, and Contraindications sections of the prescribing information for micro-bubble contrast agents. Drug Information
  • New and Generic Drug Approvals
  • Roxane Laboratories informs healthcare professionals of the recall of two lots of Sodium Polystyrene Sulfonate Suspension, a product used to treat hyperkalemia. MedWatch Safety Information

July 16, 2008


Update: 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 21 Jul 2008 15:49:44 -0500 (CDT)
Subject: CDER New 7/21/2008

FDA Logo links to FDA home page
Center for Drug Evaluation and Research, U.S. Food and Drug Administration
HHS Logo links to Department of Health and Human Services website

CDERnew Logo

July 21, 2008


Message: 5
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 21 Jul 2008 16:02:50 -0500 (CDT)
Subject: Are You Storing Food Safely?

Are You Storing Food Safely?
Mon, 21 Jul 2008 15:48:00 -0500

When, where, and how you store food can help prevent foodborne illnesses. Here are pointers for safely storing food in your refrigerator, freezer, and cupboards.


Update: 6
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 21 Jul 2008 16:20:21 -0500 (CDT)
Subject: FDA News Digest

FDA News Digest

July 21, 2008

_____________________________________

IN THIS WEEK'S ISSUE

» News

-- FDA Fellowship Program Aims to Attract Scientists, Other Professionals

-- $1.1 Million Settlement Reached with California Hearing Device Maker

» Congressional Testimony

» Safety Alerts/Recalls

» Upcoming Public Meetings

» Consumer Health Information

__________________________________________

NEWS

FDA Fellowship Program Aims to Attract Scientists, Other Professionals

FDA is launching a two-year fellowship program aimed at attracting scientists, engineers and health professionals to the agency. The FDA Commissioner’s Fellowship Program will provide participants with advanced training in the scientific analysis involved in the safety and regulatory decisions unique to the agency’s mission.

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01861.html

$1.1 Million Settlement Reached with California Hearing Device Maker

FDA has reached a settlement with California hearing device manufacturer Advanced Bionics LLC and its president and CEO, Jeffrey Greiner, over alleged federal violations involving the failure to notify FDA of a change in outside supplier, which may have exposed patients to unnecessary health risks, such as device failure and surgery. Under the terms of the settlement, Advanced Bionics will pay a civil penalty of $1.1 million, and Greiner will pay $75,000.

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01860.html

To view an archive of recent FDA news releases, go to

To access the RSS feed of FDA news releases, go to

http://www.fda.gov/bbs/topics/news/rssPress.xml.

[What is an RSS feed? See http://www.fda.gov/bbs/topics/news/newsfeeds.html.]

_____________________________________________

CONGRESSIONAL TESTIMONY

July 9 -- FDA Associate Director of Safety Policy and Communication Paul Seligman, M.D., appeared before the House Committee on Veterans' Affairs.

Subject: FDA's drug safety initiatives

http://www.fda.gov/ola/2008/PTSDdrugs070908.html

To view an archive of past testimony by FDA officials, go to

http://www.fda.gov/ola/listing.html

__________________________________________________________

SAFETY ALERTS/RECALLS

For a list of recalls, market withdrawals, and safety alerts involving FDA-regulated

products from the past 60 days, go to http://www.fda.gov/opacom/7alerts.html.

To access the RSS feed of FDA recalls information, go to

http://www.fda.gov/oc/po/firmrecalls/rssRecalls.xml

[What is an RSS feed? See http://www.fda.gov/bbs/topics/news/newsfeeds.html.]

____________________________________________________________________

UPCOMING PUBLIC MEETINGS

Sept. 8-10 -- Parenteral Drug Association (PDA)/FDA Joint Regulatory Conference

Location: Washington, D.C.

http://www.pda.org/webmodules/webarticles/templates/new_conferences_2008_PDA_FDA.aspx?articleid=1453&zoneid=190

Sept. 10-12 -- Parenteral Drug Association (PDA)/FDA Pharmaceutical Ingredient Supply Chain Conference

Location: Washington, D.C.

http://www.pda.org/webmodules/webarticles/templates/2008_PDA-FDA_Pharmaceutical_Ingredient_Supply_Chain_Conference.aspx?articleid=1803&zoneid=233

For a complete list of upcoming meetings, seminars, and other public events sponsored

or co-sponsored by FDA, go to http://www.fda.gov/opacom/hpmeetings.html.

CONSUMER HEALTH INFORMATION

Consumer updates in the spotlight this week are:

FDA 101: Advisory Committees

http://www.fda.gov/consumer/updates/advisory_committees070108.html

Radiology and Children: Extra Care Required

http://www.fda.gov/consumer/updates/radiology_kids062308.html

To receive all consumer updates by e-mail, go to http://www.fda.gov/consumer/consumerenews.html.

For the latest in consumer health news from FDA, visit http://www.fda.gov/consumer/default.htm.

Thanks for subscribing to FDA News Digest.

Our next issue will be sent July 28.

Comments about FDA News Digest?

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Update: 7
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 21 Jul 2008 18:02:44 -0500 (CDT)
Subject: Agricola Zaragoza, Inc. Recalls Jalapeno Peppers Because of Possible Health Risk (July 21)

Agricola Zaragoza, Inc. Recalls Jalapeno Peppers Because of Possible Health Risk (July 21)
Mon, 21 Jul 2008 17:11:00 -0500

The recall is a result of sampling by FDA, which revealed that these Jalapeno Peppers were contaminated with the same strain of Salmonella Saintpaul responsible for the current Salmonella outbreak. It is unknown at this time which, if any, of the more than 1,200 illnesses reported to date are related to this particular product or to the grower who supplied this product. Distribution of these products has been suspended while FDA, the Texas Department of State Health Services and the company continue their investigation as to the source of the problem.


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