FDA… Food Recalls, Safety Alerts

FDA News Digest

March 24, 2008

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IN THIS WEEK’S ISSUE

»  News

    – FDA Approves New Medical Adhesive to Treat Burn Patients

»  Safety Alerts/Recalls

»  Upcoming Public Meetings

»  Consumer Health Information

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NEWS

FDA Approves New Medical Adhesive to Treat Burn Patients

FDA has approved Artiss, a medical adhesive for use in attaching skin grafts onto burn patients. The product contains fibrinogen and thrombin, two proteins essential in the clotting of blood. Artiss differs from other similar sealants because it contains a lower concentration of thrombin, allowing surgeons time to position skin grafts over burns before the graft begins to adhere to the skin. 

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01807.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.]

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SAFETY ALERTS/RECALLS

Safety Alert:

Following reports of 50 illnesses in 16 states, FDA has issued an import alert regarding cantaloupe from Agropecuaria Montelibano, a Honduran grower and packer. Based on current information, fruit from this company appears to be associated with a Salmonella outbreak in the United States and Canada. The import alert advises FDA field offices that cantaloupes shipped to the United States by this company are to be detained. FDA also has contacted importers about this action and is advising U.S. grocers, food service operators, and produce processors to remove any cantaloupes that come from this company. 

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01808.html

Food Recalls:

 Acme 4-pack Cinnamon Rolls with Icing (sold in New Jersey, Pennsylvania, Delaware, and Maryland)

Reason for recall: milk component not declared on label

http://www.fda.gov/oc/po/firmrecalls/acme03_08.html

Certain lots of Bass Pro Shops Uncle Buck’s Light ‘n Krispy Original (8 oz. pouches and 22-oz. size) and Light ‘n Krispy Hot & Spicy (22-oz. size) fish batter mixes; sold in Bass Pro Shops nationwide

Reason for recall: milk component not declared on label

http://www.fda.gov/oc/po/firmrecalls/williams03_08.html

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.]

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UPCOMING PUBLIC MEETINGS

March 25 — Pediatric Advisory Committee

    Under discussion: adverse events reports for several drugs

    Location: Gaithersburg, Md.

http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-1296.htm

April 1-2Anti-Infective Drugs Advisory Committee

    Under discussion: product development and clinical trial design for community-acquired pneumonia

    Location: Beltsville , Md.

http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-814.htm

 

April 4Quality System Regulation Educational Forum on Design Controls, a public workshop for regulated industry, especially small businesses

    Location: Dallas, Texas

http://www.fda.gov/OHRMS/DOCKETS/98fr/E7-20077.htm

April 7-8QT and Arrhythmia Issues in Drug Development

    Under discussion: development of pharmaceutical agents, as well as challenges and solutions

    Location: Bethesda, Md.

http://www.diahome.org/DIAHOME/Education/FindEducationalOffering.aspx?productID=16004&eventType=Meeting

   

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

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

 

CONSUMER HEALTH INFORMATION

Each week, we offer links to articles about FDA activities and FDA-regulated products. In the spotlight this week:

 

Getting Up to Date on Glucose Meters

http://www.fda.gov/consumer/updates/glucosemeters110107.html

 FDA’s Strategic Plan: Charting Our Course for the Future

http://www.fda.gov/consumer/updates/strategicplan022908.html

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