Counterfeit Alert from FDA
The Food and Drug Administration recently sent the following alert to the Counterfeit Alert Network
GlaxoSmithKline and FDA
informed healthcare professionals in a
Dear Pharmacy Professional Letter of an
apparent third-party tampering that
resulted in the misbranding of Ziagen as
Combivir and employed counterfeit
labels for Combivir Tablets. Both medications
are used as part of combination
regimens to treat HIV+ infection. Two
60-count misbranded bottles of Combivir
Tablets contained 300 mg tablets of Ziagen.
The counterfeit labels identified
are Lot No. 6ZP9760 with expiration dates of
April 2010 and April 2009. The
incident appears to be isolated and limited
in scope to one pharmacy in
California. Pharmacists should immediately
examine the contents of each bottle
of Combivir in their pharmacy to confirm that
the bottles contain the correct
medication. The Dear Pharmacy Professional
Letter contains photos of actual
Combivir and Ziagen Tablets. If a bottle
contains anything other than Combivir
Tablets, pharmacists should notify the
manufacturer.
A copy of the letter (with interactive links
to photos) can be found at:
http://www.fda.gov/medwatch/safety/2007/Ziagen_Dear_RPh_03-29-2007.pdf
About The SafeMeds Alert System
The SafeMeds Alert System is a counterfeit alert
distribution service of the the Partnership
for Safe
Medicines--a group of
organizations and individuals that have policies,
procedures, or programs to protect consumers from
counterfeit or contraband medicines.
