FDA News Digest for May 16, 2005 RECALS

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FDA News Digest

May 16, 2005

 

 

IN THIS WEEK'S ISSUE

 

-- First DNA-Based Blood Test Approved to Detect Cystic Fibrosis

-- FDA Warns of Counterfeit Drugs Sold in Mexican Pharmacies

-- Recalls/Market Withdrawals

-- Public Meetings

-- Question of the Week

 

 

First DNA-Based Blood Test Approved to Detect Cystic Fibrosis

 

FDA has approved the Tag-It Cystic Fibrosis Kit, which analyzes human DNA to find genetic variations that could indicate the presence of cystic fibrosis. The test can be used to help diagnose the disease in children and to identify adults who could be carriers of the genetic variations. In the United States, cystic fibrosis affects one in 2,500-3,300 Caucasian babies, half of whom die by age 30.

http://www.fda.gov/bbs/topics/NEWS/2005/NEW01178.html

 

FDA Warns of Counterfeit Drugs Sold in Mexican Pharmacies

 

FDA is warning consumers about the sale of counterfeit versions of Lipitor, Viagra, and an unapproved product called "generic Evista" at pharmacies in Mexican border towns. The drugs were found to have little or no active ingredient. FDA urges consumers who have any of these drugs not to use them and to contact their doctors immediately.

http://www.fda.gov/bbs/topics/ANSWERS/2005/ANS01357.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

 

 

RECALLS/MARKET WITHDRAWALS

 

Safety Alert: LifeScan Inc. a maker of blood glucose testing systems for people with diabetes, is notifying users of OneTouch Ultra, OneTouch FastTake, and InDuo meters that it may be possible for meter users to misinterpret their blood glucose results due to an accidental change in the meter's unit of measure. The company is instructing patients to confirm their meter's unit of measure with each use.

http://www.fda.gov/oc/po/firmrecalls/lifescan04_05.html

 

The following products are being recalled for the reasons shown. Go to the linked pages for more information.

 

Various 7-Eleven Grilled Sandwich and Big Eats brand sandwiches (possible Listeria monocytogenes contamination)

http://www.fda.gov/oc/po/firmrecalls/prime05_05.html

 

Tan Nam Fresh Soymilk; 16-oz. and 64-oz. sizes (undeclared cow's milk)

http://www.fda.gov/oc/po/firmrecalls/tannam05_05.html

 

Various YTS Group vegetarian products (undeclared eggs)

http://www.fda.gov/oc/po/firmrecalls/yts05_05.html

 

Quik'n Tasty Foods Inc.'s Po Boys (lunchmeat, ham and cheese sandwiches) (possible Listeria monocytogenes contamination)

http://www.fda.gov/oc/po/firmrecalls/quikntasty05_05.html

 

Cloud Nine Premium Dark Orange and Dark Chocolate Bar (undeclared dairy products)

http://www.fda.gov/oc/po/firmrecalls/nspired05_05.html

 

Jilbert Dairy Vanilla Supreme ice cream; pint and half-gallon sizes (possible Listeria monocytogenes contamination)

http://www.fda.gov/oc/po/firmrecalls/jilbert05_05.html

 

Sino Bestfood Inc.'s 9.88-oz. packages of preserved fruit (apricot) (undeclared sulfites)

http://www.fda.gov/oc/po/firmrecalls/sino05_05.html

 

Certain lots of Simplastin HTF, a reagent used in laboratory monitoring of anticoagulant therapy (mislabeling could cause inaccurate test results)

http://www.fda.gov/oc/po/firmrecalls/biomerieux05_05.html

 

MRL Inc.'s AED 20 Automatic External Defibrillator (possible malfunction)

http://www.fda.gov/oc/po/firmrecalls/mrl05_05.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

 

 

PUBLIC MEETINGS

 

May 17 -- Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee; under discussion: a premarket application for a spectroscopy-based cervical imaging system (Gaithersburg, Md.)

http://www.fda.gov/oc/advisory/accalendar/2005/cdrh12524d051705.htm

 

May 18-19 -- Drug Safety and Risk Management Advisory Committee; under discussion: FDA's risk management program for marketed drugs (Silver Spring, Md.)

http://www.fda.gov/oc/advisory/accalendar/2005/cder12535dd05181905.html

 

May 19 -- Antiviral Drugs Advisory Committee; under discussion: application for approval of a new drug to treat HIV infection (Gaithersburg, Md.)

http://www.fda.gov/oc/advisory/accalendar/2005/cder12531d051905.html

 

May 20 -- Cellular, Tissue and Gene Therapies Advisory Committee; under discussion: an update on individual research programs in the Division of Therapeutic Proteins, Center for Drug Research and Evaluation (Rockville, Md.)

http://www.fda.gov/oc/advisory/accalendar/2005/cber12389d052005.html

 

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 does FDA do with defective products?

 

Products found to be unfit for consumers are withdrawn from the marketplace, either by voluntary recall or by court-ordered seizure. These products usually are destroyed, or in some cases, they are reconditioned to be in compliance with FDA regulations.