Ziagen/Combivir Alert
GlaxoSmithKline and FDA
March 2007
 
GlaxoSmithKline and FDA informed healthcare professionals 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.

Read the complete MedWatch 2007 Safety summary, including a link to the firm's
"Dear Pharmacy Professional Letter" regarding this issue, at:
http://www.fda.gov/medwatch/safety/2007/safety07.htm#Ziagen