FDA News Digest
December 6,
2004
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IN THIS WEEK'S ISSUE
-- Final Rule Issued on Records Needed to Protect Food Supply
-- Adverse Effects Prompt Labeling Change
for Two Penicillin Products
-- FDA Takes Action Against Company for
Illegally Importing Rx Drugs
-- Recalls/Market Withdrawals
-- Recent Speeches
-- Public Meetings
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Adverse Effects Prompt Labeling Change for Two Penicillin Products
FDA has announced a labeling change
for the antibiotics Bicillin CR (penicillin G benzathine and penicillin G
procaine injectable suspension) and Bicillin LA (penicillin G benzathine
injectable suspension). The changes include a boxed warning against intravenous
use and a precautionary note explaining that Bicillin CR is not for treatment of
syphilis. Intravenous use of both products has been associated with serious
adverse effects.
http://www.fda.gov/bbs/topics/ANSWERS/2004/ANS01329.html
FDA Takes Action Against Company for
Illegally Importing Rx Drugs
A civil complaint filed in a
district court on FDA's behalf seeks to prevent Canada Care Drugs, Inc., from
illegally importing prescription drugs. An FDA investigation revealed several
products the company sold that pose a public health risk.
http://www.fda.gov/bbs/topics/news/2004/NEW01142.html
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RECALLS/MARKET
WITHDRAWALS
The following products
are being recalled for the reasons shown. Go to the linked page for more
information.
ACTRA-Rx dietary
supplement (may contain unlabeled prescription drug
ingredient)
http://www.fda.gov/oc/po/firmrecalls/bodybasics12_04.html
Pulmonetic Systems
universal cable adaptors, used to power medical ventilators (could cause
ventilator malfunction)
http://www.fda.gov/oc/po/firmrecalls/pulmonetic12_04.html
Hospitak, Viasys,
Unomedical, and Drager Medical airway adapters (possible blockage
problems)
http://www.fda.gov/oc/po/firmrecalls/unomedical12_04.html
Organica Foods Double
Chocolate Coffee Toffee Cookies; 6.5-oz. packages (undeclared
walnuts)
http://www.fda.gov/oc/po/firmrecalls/summerland11_04.html
Nature's Plus Animal
Parade Children's Chewable Calcium, Natural Vanilla Sundae Flavor, and sample
packets of both (undeclared casein)
http://www.fda.gov/oc/po/firmrecalls/naturalorg12_04.html
American Health &
Herbs Ministry eye rinse products; four varieties in 2- and 8-oz. sizes
(possible lack of sterility)
http://www.fda.gov/oc/po/firmrecalls/americanhealth12_04.html
Tosoh Bioscience
AIA-600 II Analyzers (produces false positive and false negative
results)
http://www.fda.gov/cdrh/recalls/recall-040203.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
http://www.fda.gov/oc/po/firmrecalls/rssRecalls.xml
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RECENT SPEECHES
FDA Acting
Commissioner Lester M. Crawford, D.V.M., before the Health Care Research and
Innovations Congress; subject: FDA's "Calories Count" initiative (Dec.
1).
http://www.fda.gov/oc/speeches/2004/obesity1201.html
To view an archive of
past speeches by FDA officials, go to http://www.fda.gov/speeches/speechli.htm
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PUBLIC
MEETINGS
Jan. 12-13 -- Industry Exchange Workshop on FDA
Clinical Trial Requirements (San Francisco)
http://www.fda.gov/OHRMS/DOCKETS/98fr/04-26092.htm
For a list of upcoming
FDA meetings, seminars, and other public events, go to
http://www.fda.gov/opacom/hpmeetings.html
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