Skip to Content

Combivir FDA Alerts

The FDA Alert(s) below may be specifically about Combivir or relate to a group or class of drugs which include Combivir (lamivudine/zidovudine).

MedWatch Safety Alerts are distributed by the FDA and published by Following is a list of possible medication recalls, market withdrawals, alerts and warnings. For the latest FDA MedWatch alerts, go here.

Recent FDA Alert(s) for lamivudine/zidovudine

Combivir (lamivudine and zidovudine) Tablets

Apr 10, 2007

Audience: Pharmacists, other healthcare professionals

[Posted 04/10/2007] 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.

[March 29, 2007 - Letter - GlaxoSmithKline]

Combivir (lamivudine plus zidovudine)

May 10, 2002

Audience: Pharmacists, distributors, and healthcare professionals

GlaxoSmithKline announced that the company received four reports of suspect bottles containing 60 tablets of Combivir (lamivudine plus zidovudine) that actually contained another medicine, Ziagen (abacavir sulfate) Tablets. The company has determined that counterfeit labels for Combivir Tablets were placed on two bottles of Ziagen and labels on another two bottles are suspect. Both medicines are used as part of combination regimens to treat HIV infection. The incidents appear to be isolated and limited in scope. No injuries or adverse reactions have been reported. Company tests have shown no problems with the medicine itself.

[May 14, 2002 Letter to Healthcare Professionals - GlaxoSmithKline] PDF Format
[May 14, 2002 Letter to Pharmacists - GlaxoSmithKline] PDF Format
[May 10, 2002 Press Release - GlaxoSmithKline]

More Combivir Resources