FDA News Digest for May 31, 2005

[FDA News Digest <fdanewsdigest@xxxxxxxxxx>]

Title: Message

 

FDA News Digest

May 31, 2005

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IN THIS WEEK'S ISSUE

 

--  Web Site Explains New Devices for Correcting Nearsightedness

--  FDA Offers Patient Information on Recently Approved Devices

--  Recalls/Safety Alerts

--  Congressional Testimony

--  Public Meetings

--  Question of the Week

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Web Site Explains New Devices for Correcting Nearsightedness

 

To help consumers understand phakic lenses, newly approved devices that are surgically implanted to correct nearsightedness, FDA has created an information Web site. Phakic lenses are permanently implanted through a small incision and placed just in front of or just behind the iris. The site includes an animated movie that shows the anatomy of the eye and how phakic lenses fit into the eye structure.

http://www.fda.gov/cdrh/phakic/

 

FDA Offers Patient Information on Recently Approved Devices

 

FDA's Center for Devices and Radiological Health has published online consumer information on three recently approved medical devices. The information, linked on the following list, briefly describes the devices, explains what they are intended to do, and tells how they should and should not be used:

-- Liberté Monorail and Over-the-Wire Coronary Stent System (to open narrowed blood vessels)

http://www.fda.gov/cdrh/mda/docs/p040016.html

-- Restylane Injectable Gel (to smooth facial wrinkles and folds)

http://www.fda.gov/cdrh/mda/docs/p040024.html

-- GORE TAG Thoracic Endoprosthesis (to repair aortic aneurysms in the chest)

http://www.fda.gov/cdrh/mda/docs/p040043.html

 

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

http://www.fda.gov/opacom/hpnews.html.

 

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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RECALLS/SAFETY ALERTS

 

Recall Alert:

 

FDA is alerting the public that Able Laboratories is conducting a nationwide recall of all of its manufactured drugs because of concerns that these products were not produced according to quality assurance standards. Products under the recall are mostly generic prescription drugs, including ones containing acetaminophen. For a complete listing of the recalled drugs go to http://www.fda.gov/bbs/topics/NEWS/2005/NEW01182.html.

 

Other Recalls:

 

Edwards Turtle Pie Single 2-pack frozen pie slices, date code Y85071

Reason for recall: undeclared eggs

http://www.fda.gov/oc/po/firmrecalls/schwan05_05.html

 

California Specialty Produce's Red Pear Tomatoes

Reason for recall: possible Salmonella contamination

http://www.fda.gov/oc/po/firmrecalls/caspecialty05_05.html

 

Trader Joe's Mole Rojo Sauce, product # 71534

Reason for recall: inferior quality

http://www.fda.gov/oc/po/firmrecalls/traderjoe05_05.html

 

Ghandour Halva, all flavors, regular and sugar free

Reason for recall: possible Salmonella contamination

http://www.fda.gov/oc/po/firmrecalls/ziyad05_05.html

 

Seyfert's Original Kettle Cooked Potato Chips, Lot # 0720B15

Reason for recall: undeclared milk, whey, and yellow dye #5

http://www.fda.gov/oc/po/firmrecalls/seyfert05_05.html

 

aSPICES brand Basil, Ground; 1-oz. bags

Reason for recall: possible Salmonella contamination

http://www.fda.gov/oc/po/firmrecalls/american05_05.html

 

Ho's Trading Inc.'s Home Special Soup Mixed, Dessert of Pear

Reason for recall: undeclared sulfites

http://www.fda.gov/oc/po/firmrecalls/ho05_05.html

 

Ho Ho Market Inc.'s Dried Polygonatum (Vegetable); 12-oz. bags

Reason for recall: undeclared sulfites

http://www.fda.gov/oc/po/firmrecalls/hoho05_05.html

 

American Dragon Trading Corp.'s Chinese Candy; 12-oz. bags

Reason for recall: undeclared sulfites

http://www.fda.gov/oc/po/firmrecalls/americandragons05_05.html

 

Sunny Lake Trading's Sweet Potato Slice; 6-oz. bags

Reason for recall: undeclared sulfites

http://www.fda.gov/oc/po/firmrecalls/sunnylake05_05.html

 

Sun Kee brand Dried Sweet Potato; 12-oz. packages 

Reason for recall: undeclared sulfites

http://www.fda.gov/oc/po/firmrecalls/sunkee05_05.html

 

 

Note: FDA has created an free e-mail list that allows you to receive press releases about recalls of FDA-regulated products. The list only covers Class 1 (life-threatening) recalls. To sign up, go to http://list.nih.gov/cgi-bin/wa?SUBED1=fda-recalls-l&A=1.  

 

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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CONGRESSIONAL TESTIMONY

 

May 17 -- FDA Center for Food Safety and Applied Nutrition Director Robert E. Brackett, Ph.D., appeared before the House Subcommittee on the Federal Workforce and Agency Organization.

Subject: the federal food safety system

http://www.fda.gov/ola/2005/foodsupply0517.html

 

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

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

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PUBLIC MEETINGS

 

June 8 -- Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee

Under discussion: FDA's Critical Path Initiative and issues related to postmarket study design.

Location: Gaithersburg, Md.

http://www.fda.gov/oc/advisory/accalendar/2005/cdrh12523d060805.html

 

June 10 -- Advisory Committee on Special Studies Relating to the Possible Long-Term Health Effects of Phenoxy Herbicides and Contaminants

Under discussion: the possibility of a comprehensive study report derived from an Air Force Health Study.

Location: Rockville, Md.

http://www.fda.gov/oc/advisory/accalendar/2005/nctr12560d061005.html

 

June 13-14 -- Workshop on Biological Products for Treatment of Rare Plasma Protein Disorders

Under discussion: Scientific and regulatory challenges in development of these products.

Location: Bethesda, Md.

http://www.fda.gov/OHRMS/DOCKETS/98fr/05-9011.htm

 

For a list of FDA meetings, seminars, and other public events, go to

http://www.fda.gov/opacom/hpmeetings.html.

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QUESTION OF THE WEEK

 

What should you do if you've had an adverse reaction to an over-the-counter or prescription medicine?

 

Contact your doctor right away and urge him or her to report the problem to the FDA MedWatch hotline (1-800-FDA-1088). Your doctor, however, is not required to report to FDA. Therefore, consumers can report problems directly. For more information, visit the MedWatch Web site at http://www.fda.gov/medwatch/.

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