Tampering Led to Misbranding of Ziagen as Combivir, counterfeit labels

April 10, 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.

see also:

'Dear Doctor' Letter Letter Informs Health Workers of Misbranded Ziagen & Combivir Tablets
HIV Meds Misbranded; Letter Details Tampering of Ziagen and Combivir

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