FDA News Digest
May 2,
2005
___________________________________________________________
IN THIS WEEK'S
ISSUE
-- GlaxoSmithKline Agrees to Correct
Drug Manufacturing Problems
-- 'Diverted' Drugs Scheme Shut Down; List of Affected
Medicines Posted
-- Glavin to Succeed Taylor as Head of FDA
Regulatory Affairs
-- Recalls/Market
Withdrawals
-- Public Meetings
___________________________________________________________
GlaxoSmithKline Agrees to Correct
Drug Manufacturing Problems
Drug manufacturer GlaxoSmithKline
has signed a court-ordered consent decree, agreeing to correct manufacturing
deficiencies at a Puerto Rico facility that resulted in production of two drug
products that could pose risks. FDA inspections of the facility found Paxil CR
tablets, approved to treat depression and panic disorder, could split apart. The
agency also found that some Avandamet tablets, approved to treat Type II
diabetes, did not have an accurate amount of an active
ingredient.
http://www.fda.gov/bbs/topics/news/2005/NEW01176.html
'Diverted' Drugs Scheme Shut Down;
List of Affected Medicines Posted
FDA and the Department of Justice
have announced indictments against several prescription drug distributors that
illegally distributed "diverted" drugs, which bypass established distribution
systems that help ensure quality. The scheme could affect the safety and
effectiveness of more than 40 medications sold in more than 80 pharmacies
nationwide. FDA urges consumers to check the list of drugs and pharmacies at http://www.fda.gov/bbs/topics/answers/2005/ANS01353lists.html
to determine if they may have bought a diverted drug
product.
http://www.fda.gov/bbs/topics/ANSWERS/2005/ANS01353.html
Glavin to Succeed Taylor as Head of
FDA Regulatory Affairs
John M. Taylor III, a 14-year FDA
veteran who most recently has served as associate commissioner for regulatory
affairs, is leaving the agency. Margaret O'K. Glavin has been named to succeed
Taylor in that position. She brings to the job extensive background in crisis
management and food safety.
http://www.fda.gov/bbs/topics/news/2005/NEW01177.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
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RECALLS/MARKET
WITHDRAWALS
The following products are being
recalled for the reasons shown. Go to the linked pages for more
information.
Moi-Stir Oral Swabsticks (may
contain molds that could result in respiratory infections)
http://www.fda.gov/oc/po/firmrecalls/kingswood04_22.html
One lot of Famotidine Injection
(lack of sterility assurance)
http://www.fda.gov/oc/po/firmrecalls/bedfordlabs04_05.HTML
CM 100-Heartstart Adapter Cable,
Cat. No. 920650 (wires in the cable may break)
http://www.fda.gov/oc/po/firmrecalls/Laerdal04_05.pdf
An additional 396 monophasic LifePak
360 automated external defibrillators (may malfunction)
This is an extension of a recall that began in February.
http://www.fda.gov/oc/po/firmrecalls/lifepak04_25.html
Sino Bestfood Inc.'s preserved fruit
(apple) (undeclared sulfites)
http://www.fda.gov/oc/po/firmrecalls/SinoBestfood04_05.html
Assi Brand Dried Bellflower Root
(undeclared sulfites)
http://www.fda.gov/oc/po/firmrecalls/rheebros04_05.html
For a list of recalls, market
withdrawals, and safety alerts involving FDA-regulated products from the last 60
days, go to
http://www.fda.gov/opacom/7alerts.html
To access the RSS feed of FDA
recalls information, go to
For a list of
FDA meetings, seminars, and other public events, go to
http://www.fda.gov/opacom/hpmeetings.html
_____________________________________________________________
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